Juan C. Fernandez
1374 SW 159th
Lane
Pembroke Pines, Florida 33027
954-885-0404 (H)
954-536-3220 (C)
fern5407@bellsouth.net
LinkedIn shortcut;
https://www.linkedin.com/profile/public-profile-settings?trk=prof-edit-edit-public_profile
A “hands on”, results oriented, professional with over 29 years of experience managing high performance teams in such
areas as Manufacturing Operations. Other areas of responsibility included Quality Assurance, Risk Management,
Complaint Handling, Regulatory Affairs Customer Service Warehousing, Distribution, Product, Process & Manufacturing
engineering, Manufacturing (in-house and contract), Order and procurement Planning, Project management,
Environmental Health & Safety, Human resources, Finance & Facilities and Equipment Maintenance Management roles in
the medical device, pharmaceutical & automotive industry. I am also a Certified Six Sigma Green Belt & Process
Champion.
I employ a team-based, leadership style, which encourages & promotes innovative risk taking, continuous improvement,
career development & a skill-learning environment. I am a problem solver, with particular strengths in managing crisis &
turn around situations, as well as identifying & maximizing on opportunities.
The values I bring to your organization are:
Business skills and Ownership; A technical leader; with demonstrated strengths in managing technical and non-technical
resources to achieve organizational, product build and launch objectives. Management style provides mentoring &
guidance while instilling an environment for achievement & development. Creating common objectives & standards,
coordinating, leading, training & leveraging cross functional teams (Mfg., PD, QA, S&M, EHS, Facilities, sales &
marketing) operating both locally & at international sites; Developed Project management operations and systems required
to run and sustain the business. Developed manufacturing strategies / plans targeted at increased revenue and business
growth. Met quarterly with Board of Directors.
Quality Assurance & Regulatory
Designated as the site representative and point of contact for inspection agencies such as FDA, OSHA, EPA, TUV, DQS,
BSI, FCC, TUV, ETL. Emergo. In addition was also familiar with requirements for such agencies as AHCA, JCAHO
(TJC), NFPA, ADA, HRS. Monitor performance metrics as well as survey agencies in industry for regulation changes.
Financial Accountability; Accountable for Department and organizational P&L, site capital budget, product costing,
sales forecasting and demand planning, schedule performance, project timelines, cost of quality measures, capital asset
management, & inventory levels.
Continuous improvement; Certified Lean Six Sigma Green Belt & Process Champion, as well as Environmental, Health
and Safety lead. Fostered a success oriented, cost sensitive environment. Developed and motivated high performance
management team. Established business performance targets and reviewed metrics monthly with Sr. Mgmt. team and
quarterly with Board of Directors.
Functional exp. / Skills; Project management, Manufacturing, Procurement, Distribution, warehouse, Engineering
(process, Manufacturing, Product, software, facilities), Environmental Health & Safety, Risk Management, Human
Resources, Corporate Compliance, Customer Service center, Facilities management & Quality Assurance (supplier,
Manufacturing, Product development, In house QMS), Regulatory, budgeting, mentoring, coaching, computer / software
literate.
Project management; Experience projects leader of various program types (product / process development, facilities,
Mfg., QA & Regulatory) budgeted & valued in excess of Millions of dollars. Establish user requirements, developing
timelines & budgets, managing resources & communicating status. Work with project teams to identify activities / task,
risk & their contingencies, resource planning, timeline generation; hold project teams accountable & provide continuous
feedback to team members in terms of significant changes in direction or performance. Ability to effectively work &
communicate with members of various functional teams throughout organization and communicate status updates to Sr.
Management team as well as Board of Directors. Participate in development of global strategic & tactical objectives.
As an experienced professional within your organization, I would deliver results through such talents as leadership,
communication, program management, financial planning & team building.
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Resume of
Juan C Fernandez
Juan C. Fernandez
1374 SW 159th
Lane
Pembroke Pines, Florida 33027
954-885-0404 (H)
954-536-3220 (C)
fern5407@bellsouth.net
Professional Experience
MEDDEVICE Manufacturing Solutions, LLC. Dec. 2014 to Present
Professional turnkey consulting service specializing in manufacturing and associated logistics for Medical Device
Companies.
Manage day to day activities related to business operations. Provide specialized services to clients requesting assistance in
establishing / optimizing medical device manufacturing process and logistics. Other areas classified as logistics include,
supplier sourcing, procurement, warehouse inventory, distribution, forecasting, budgeting, manufacturing team sourcing
(technical and non-technical), Project Management, Quality Assurance, Regulatory, Environmental Health and Safety,
Facilities Management, Risk Management, Corporate Compliance, Human Resources, Engineering (product, process,
software, and manufacturing). Agencies which I communicate with include FDA, OSHA, TUV, DQS, UL, FCC, ETL,
Emergo.
Significant Achievements / services provided include;
Manufacturing / Operations
Medical Device Sterilization Process & Control, Sterilization & Re-sterilization of Medical Devices
Support functions within medical device companies, Sterilization and tracking of product
Supplier / Procurement
Develop & implement Contract Manufacturer / supplier system which included contractor / supplier
identification and assessment program, Medical Device Mfg. / MRO Supplies Sourcing
Quality Assurance& Regulatory
Medical Device Crisis & Risk Management, Perform QMS system audits and feedback, .Provide outlines of
requirements for sustainable & compliant QMS system; establish QMS and regulatory systems as required for
specific products manufactured.
Facilities Manager
Provide guidance on waste management requirements as required per EMS 14001
Environmental Health & Safety
Guide with establishing OSHA Safety programs as per OSHA CFR29 (Programs such as such as Lockout tag-
out, forklift safety, Personal protective equipment, ect), Establish waste material disposal process as per EMS
14001, Establish OSHA log tracking and reporting system.
Human Resources
Internal vs. External HR support
Director of Operations Vossen Wheels Inc. July 2014 to Feb. 2015
Designer & manufacturer of aftermarket wheels for high end automobiles
Spear head day to day activities with oversight of resources (engineering, manufacturing, supply chain (procurement,
inventory management, manufacturing, warehousing, distribution) sales marketing, and Quality assurance in ensuring we
deliver the correct ordered product in a timely manner, while ensuring the upmost quality. Manage facilities and
maintenance program; address planned and unplanned audits (TUV, OSHA, DERM,); I manage a team of 47 resources. I
hold monthly Sr. Mgmt. team meeting; Established “operations”, Engineering, Project Management and Quality Systems
from ground up; additional responsibilities include, staffing, customer service, Product Development Engineering,
Environmental Health & Safety, Responsible for both internal and external manufacturing and supplier resources and
activities. Significant Achievements include;
Manufacturing / Operations
First manufacturing builds / new mfg. line in 3 weeks from employment start date; Re-aligned mfg. & Eng. to
maximize sales order deliveries; Initiated Sales Ops Mtg.; Implement Capital & Expense budget sheet;
Implement performance metrics; Established Manufacturing schedules & inventory management tracking;
Supplier / Procurement
Develop & implement Contract Manufacturer / supplier system which included contractor / supplier assessment
program, Establish procurement / Invoice program which aimed at (1) price reduction (2) systemize method of
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Resume of
Juan C Fernandez
procuring materials; ensure timely payment of invoices.
Customer Service
Established Customer & technical service support system, Established metrics tracking for complaint calls.
Engineering & Project Management
Established project management program to drive projects from R&D to launch, This also entailed project
progress tracking method, cost tracking and customer feedback process; Identified and incorporated necessary
engineering tools (IE computers and software) required; Identified necessary training for engineers so as to
acquaint them with the software used to generate designs and software for the manufacturing machine.
Quality Assurance& Regulatory
Established documentation control system to manage revision controlled documents and programs; Implement
receiving inspection process; Implemented complaint and product return process; Implement Risk Management
program; Instituted design verification method for product (FEA); Acquired TUV certification allowing for
distribution outside of US.
Facilities Manager
Managed site related facility modifications; Managed county & state inspection and permit agencies; Worked
with contractors to ensure installation of equipment and utilities and other facility related requirements; Was
point of contact for utility companies.
Environmental Health & Safety
Established Safety programs as per OSHA CFR29 (IE; Lockout tag-out, forklift safety, Personal protective
equipment, ect); As per ISO 14001, establish waste material pickup, disposal & manifest system.
Human Resources
Instituted Hiring agreements. Developed job Descriptions, interviewed candidates and extended job offers.
Established benefits package for hew hires & existing employees; Develop Salary scale; Develop Performance
Assessment process; Worked with Dept. of Labor to establish worker’s identities (exempts vs non exempts) &
over time requirements as well updated internal policies on new laws and requirements (IE FMLA); Served as
HR representative so as to address questions and or communications to employees.
C.O.O. / Exec. VP Operations / Corporate Compliance Officer, Orthosensor Inc. Feb. 2011 to June 2014
Start up medical device organization; Developer & manufacturer Intelligent Orthopedic Medical devices used during
Total Knee Replacement Surgery.
Very “hands on role”; Lead establishment of “operations systems” from ground up with a focus on Manufacturing,
Quality Assurance & Regulatory, Product Development Engineering and project management process. Established in
compliance with FDA ISO 13485 so as to endure design controls and traceability. Developed project timeline outlines,
manpower, work flow and financial analysis reports. Additional responsibilities included staffing, Supply Chain, Customer
& technical Service, Facilities Management, Environmental Health & Safety and Corporate Compliance program.
Accountable for department strategies, and budgets. Active participant of the board of Directors. Designated site
management representative for all internal / external audit agency / compliance related activities which included FDA,
EPA, OSHO, TUV, DQS, BSI, FCC, UL, Emergo, AHCA, JCAHO, NFPA, ADA, HRS.
Significant Achievements include;
Quality Assurance & Regulatory
Management representative for all federal and local agencies; Obtained certification to FDA ISO 13485 in less
than 4 months; Established Mfg. & QA regulatory KPI / Metrics; Established a paper-less documentation control
system per FDA requirements; also established requirements for Software used in conjunction with product;
Passed FDA initial site inspection (0 Major Observations); Passed 3rd
Party (DQS) ISO 13485 re-certification
inspection; 0 Observations; Established Risk Management process (as per ISO 14971) which included Complaint
handling, product return, failure analysis process, CAPA system and product surveillance; Established Site
Operation contingency plan; Established Product development QAE support system; Aligned internal
requirements with those of AHCA, JCAHO, NFPA, ADA, HRS so as to ensure compliance when equipment was
rolled out to hospitals.
Manufacturing Operations
Established necessary systems, relationships & expectations for Contract Manufacturers & suppliers.
Establish procurement / supplier program which aimed at price reduction & optimization of procured
components & materials as well as on time deliveries; Establish internal Product receiving, warehouse &
distribution system; Established manufacturing schedule & inventory management tracking systems;
Established Sales Ops Mtg. for collaboration & communication between Ops, Sales, Marketing & finance team
members; Established Customer & technical service support system; Established Capital & Expense budget sheet
for use by organization.
Engineering & Project Management
Delivered Generation I, Class II Electronic Medical Device, with software, to market in under 8 months;
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Establish site project management system used to track and report status of projects from R&D to launch;
Established Design control process / system for engineering management / design phase control of programs;
Utilized Contract injection molding firms for design and manufacturing of products. Two sites established as a
contingency; Formalized Design control system so as to include 6 phases (1.Mgmt Approval, 2 Feasibility 3.
Development 4. Validation Implementation 5. Launch 6. Post Market Surveillance).
Facilities Management
Sustaining & expansion efforts of building & equipment; Site representative for local agency (Fire, OSHA, EPA,
county and State) inspections;
Environmental, Health & Safety
Establish Environmental Health & Safety Programs as per OSHA CFR 29; included chemical storage, waste
disposal, & manifest management; Also included safety prevention programs for sales, office & technical team;
Developed and deployed necessary safety training to relevant members;
Human Resources
Developed job Descriptions, interviewed candidates and extended hire agreements; Instituted benefits & training
program for hew hires & existing employees; Worked with Dept. of Labor to establish worker’s identities
(exempts vs non exempts) & over time requirements; Developed and established electronic training tracking
system; Served as point of contact for employees with regards to HR policies.
Finance
Instituted initial Budget system; included capital asset mgmt. system; Instituted ERP system to track sellable
inventory and components; Implemented Contract development / approval process for all functional areas (IE
Supply chain. Clinical trials, Manufacturing, Contract employees, ect.)
Risk Management & Corporate Compliance
Implemented Corporate Compliance Program as per the Office of Inspector General. Wrote procedures and
policies for the segments of Risk Management and provided training to entire work force.
Sales
Developed initial sales forecast along with members of Product development, marketing and finance.
Identified and introduced organization to Salesforce.com
Vice President Engineering, Tridien Medical March 2010 to February 2011
Developer & manufacturer of powered (with electronics and software) & non powered support surfaces & positioners for
wound care management.
Responsible for technical and manufacturing operation of two sites (Florida 7 California). Responsible for staffing,
budgeting (Expense, sales & capital), Strategic business planning, active participant with Board of Directors, equipment
and facilities maintenance, environmental health and Safety, and manufacturing technical needs. Establish business
partnerships with customers as well as supplier. Work with in-house functional departments to set and align objectives and
projects. Established in house project management program to ensure tracking and reporting of projects. Worked closely
with QA during generation / updates of submission to FDA for product approval as well as with incorporation of new
regulatory mandates. Worked with external resources / contractors to balance internal project load as needed.
Significant Achievements include;
Engineering & Project Management
Restructure engineering teams at both sites to streamline process & optimize; Establish R&D / Eng. Inventory
management system & warehouse for non-stock items; Establish Engineering project / program management
system to include timeline design, manpower analysis, work flow structure and project status reports; Established
Engineering technology forum to discuss updates, new technologies, and for leveraging of technologies across
business; Established system for working with contractors on outsourced portions of projects;
Environmental, Health and Safety;
Institute site Safety program as per OSHA CFR 29; included chemical storage, waste disposal, & manifest
management, Also included safety prevention programs for sales, office & technical team; Developed and
deployed necessary training related to Safety programs for Sales, Engineering and Quality assurance.
Manufacturing Operations
Establish new business conduit for distribution of product; Established product training forum for sales team;
Established customer feedback system for preliminary input of new products; Established Mfg. & Engineering
performance KPI / Metrics; Established detailed Capital & Expense budget sheet for use by entire organization;
Established performance schedule & inventory management tracking systems; Established employee training /
job rotation program; Established Self-Managed Improvement Teams in Mfg.
Quality Assurance and Regulatory
Established documentation control system for engineering drawing / documentation; Reduce overdue
Engineering CAPA log by 100% in 90 days; Established Risk Management program; Aligned internal product
requirements with those of AHCA, JCAHO, NFPA, ADA, HRS, FDA, UL, FCC so as to ensure compliance to
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Resume of
Juan C Fernandez
agency and hospital requirements. Incorporate risk management program as part of engineering design controls.
Director of Engineering, Noven Pharmaceutical, Inc. June 2005 to March 2010
Developer &, manufacturer of transdermal Transmucosul drug delivery systems.
Managed engineering organization with a high emphasis on manufacturing and project management. Additional
responsibilities included Calibration, Maintenance, Environmental Health & Safety, Manufacturing, Process and industrial
Engineering technology teams and manufacturing efficiencies and schedule obtainment. Responsibilities include staffing,
budgeting, establishing department goals & managing crisis as they occur. Establishing & sustaining supplier & vendor
partnerships. Work with in-house functional departments to ensure timely completion of all product & or process
engineering related projects / programs. Work with Manufacturing to ensure timely resolution of issues as they arose as
well as to improve mfg. metrics. Also work to keep mfg. technology up to date. Lead efforts related to transfer of
technology between R&D & manufacturing as well as between manufacturing sites. Managed Mfg. / operations
department comprised of over 200 direct labor personnel (2 shift operation). Significant Achievements include;
Lean Six Sigma Methodology
Implemented Lean Six Sigma methodology at site; Certified all members of engineering organization; Lean Six
Sigma Process Champion & Green belt Certified; Maintenance & Calibration & Facilities Management
Re-Structured calibration & maintenance system; achieved 0 overdue; No major audit observation related to
internal & external system audits; Along with facilities team, implemented procedure which manage contractors
through various manufacturing area expansions projects; Awarded achievement award for facility readiness
during Hurricane seasons.
Environmental Health & safety
Enhanced site safety program with additions of various programs; Lock Out, Tag Out & Zero Access Equipment
guidelines; Enhanced site safety program with the addition of DuPont’s S.T.O.P.; Achieved 0 Incident levels for
Major and minor accidents for a period of 12 months.
Manufacturing Operations
Reduced total monthly equipment related down from 600 hrs. to 123 hrs.; Equipment Troubleshooting Guides
decreased machine down time by >75%.; Instituted Technician & Lead Machine Operator OJT program;
decreased down time by >75%.; Introduced new transdermal pouching & packaging Mfg. Lines.
Instituted Mfg. downtime tracking system; Instituted Self-Managed Improvement teams within operations &
mfg.; generated savings of >150K; Through redesign efforts, decreased the cost of machine fabrication by over
$400K; Instituted O.E.E. system with ability to view live updates via computer work stations in offices;
Instituted business development costing model for new product; Participated in Business development activities
related to new opportunities; Program Manager during transfer & scale up of product line located in California.
Engineering and Project Management
Formalized Project management process with specific timeline designs and incorporation of work and manpower
reports; Instituted R&D and manufacturing transition process for transfer of product from R&D to
manufacturing; Instituted technology forum for discussion of upgrades & new technologies (product and
Process); Worked with Regulatory to update NDA / ANDA as required; Instituted OEE system viewable from
office desk; Decreased design & fabrication cost of converter lines by $400K; Introduced Allen Bradley
controller systems across all mechanized process.
Director of Quality Assurance, VeinRX Inc. Feb 2005 to June 2005
Start up organization; Developer / manufacturer of medical devices for minimally invasive vascular (Varicose) disease
management
Head of Quality Assurance/ Regulatory and designated Site management representative for all agency related audits /
activities (IE; TUV, BSI, OSHA, EPA, FDA, FCC, UL). Responsibilities also included managing project/ timeline
management of new Quality Systems integration and new product development and introduction, supporting product
development initiatives, generating documentation, providing support to Manufacturing team and to clinical research
team, the generation / updating of Submissions to FDA for product release approval, development of project &
manufacturing strategies, departmental goals & budgets, completion of facilities related work, calibration & preventive
maintenance on equipment and Environmental Health and Safety. Responsible also included the investigation & resolution
of all technical issues related to product & manufacturing processes, CAPA system requirements, Risk Management,
Resource screening, hiring and assessing and complaint handling. Coordinated with members of Product Development,
R&D, Operations, Quality, Planning, Finance, Human Resources and Marketing & Sales to develop strategic goals for
organization.
Significant Achievements include
Quality Assurance & Regulatory
Developed & implemented site wide QMS system compliant to ISO 13485; Achieved 13485 certification for site
in less than 6 months; Established company Electronic (paperless) Doc control System; Established & ran
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Juan C Fernandez
clinical trials system which included being present in clinical setting. Managed & tracked all pertinent clinical
outcomes; Established Risk Management / product surveillance & Complaint handling program; Generated
510K submissions to FDA. Acquired approval in less than 3 months as I was able to make submission a Special
510K;Established & enforced QMS system & requirements for site; included CAPA system & complaint
management system;
Environmental Health and Safety
Established OSHA safety program as per CFR 29 across site; This included establishing process for disposal of
engineering and manufacturing waste generation.
Engineering and Project Management
Established procedure for project management system which included timeline, resource reports and set meeting
for updates; System was setup to also ensure compliance to ISO 13485’s design controls requirements.
Engineering / Operations Manager, Cordis Corp.; Jan 1988 to Feb 2005
Developer &, manufacturer of medical & combination devices for minimally invasive Cardio, Neuro & Endo vascular
disease management
Managed Engineering & operations team ( manufacturing engineering, manufacturing, planning, procurement, Quality
Assurance & facilities) assigned to Business unit; Overall duties included project/ timeline management of new process /
product introduction, manufacturing improvements, development of project & manufacturing strategies focused on
business growth, development of departmental goals & budgets, planning / execution of weekly production schedule
demand, inventory goals, the completion of facilities related work, & calibration & preventive maintenance on equipment.
Also responsible for investigation & resolution of technical issues related to the manufacturing processes / product as they
arose or were reported back from customers. Responsible for department’s Quality program (CAPA, Complaint
management & yield metrics). Coordinated with members of Product Development, R&D, Operations, Quality, Planning,
Finance, Human Resources, Marketing & Sales to develop short and long term goals for Business Unit.
Significant Achievements include;
Lean Six Sigma
Lean Six Sigma Process Champion; Saved $150K. Certified 100% of technical team to Six Sigma mythology.
Manufacturing Operations
Weekly mfg. schedule performance above 98% consistently; Managed 130 employees; Sales Operations effort to
discuss KPI’s, new opportunities & filed challenges.
Engineering & Project Management
Supported transfer of manufacturing process to OEM as well as other J&J sites; Realized a $350K annual savings
by optimizing joint fusing process; Reduced crimp band failure by 25%; Eliminated pin hole failures on stented
balloon catheters; 30% to 0%.; Re-established project management process ensuring consistency in information
and method which information was reported.
Environmental Health & Safety
Monthly training of team members on Health & Wellness, Safety practices & Quality Regulations; Also
responsible for training of employees on new process.
Process Champion /Site Compliance Prjt. Mgr., Cordis Corporation; Sept 2004 to Jan 2005
Developer &, manufacturer of medical & combination devices for minimally invasive Cardio, Neuro & Endo vascular
disease management
Lead site compliance efforts of three Johnson & Johnson, Cordis sites; (Puerto Rico, Juarez, Mx. & Miami, Fl.)
Responsible for assigning & managing resources at each site with which to execute action plan(s) aimed to address FDA
observations. Established monitoring & reporting system used to keep Johnson & Johnson Sr. Management members &
FDA abreast of progress of activities. Also lead preventive measure activities focused on avoiding the future reoccurrences
of similar observations. Reported to W.W. VP of Quality Assurance.
Significant Achievements include;
Quality Assurance
Addressed over 50% of all observations in 90 days; FDA removed warning letter based on compliance effort
results; Institution of CAPA system which ensured effectiveness prior to closure; Established Risk Management /
product surveillance & optimized Complaint handling program; Held monthly mtg. with Sr. team;
Process / Product Development Eng. (Contractor); Scion Cardiovascular; Feb 2004 to April 2004
Developers and designers of devices used in managing cerebral aneurisms.
Project manager responsible for the establishment and scale up of manufacturing process. Worked in conjunction with
QA, Regulatory and engineering to ensure manufacturing readiness for engineering, validation and initial shelf stock
quantities.
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Juan C Fernandez
Other positions held at Cordis;
Process Engineering Manager, Cordis Corp. Endovascular Division 2003 to 2004
Manufacturing / Process Development Lead Engineer (Cardiology) 1995 to1996
Product Development Engineer (Cardiology) 1993 to 1995
Product Performance / Complaint Lab Technician 1986 – 1988
Aircraft Maintenance / Special Operations Team member U.S. Air Forces 1982 - 1988
Responsible for 22 assigned aircraft as well as management & development of 55 airmen.
Member of Air Force Special Operations Tactical Teams; SRT
Significant Achievements included;
Honorably Discharged
Several Service awards obtained (Achievement, Commendation, Longevity, Distinguished Unit)
Specific Skills
Leadership, management, Inventory management, Supply Chain, Quality Assurance, Manufacturing, Six Sigma, Facilities
Management, Green Belt, Process Champion, Computer literate, word, excel, PowerPoint, Visio, MSproject, software
validation, product validation, product development, project management, process validation, design of experiments,
DOE, FDA, ISO, 13845, CFR 29, Environmental Health and safety, OSHA, EPA, EMS 14001, AHCA, JCAHO, NFPA,
ADA, HRSA mentoring, problem solving, budgeting, finance, strategy, supplier management, warehousing, distribution,
contractor management, training, Statistical Process Control, regulatory, Regulatory submission, Risk Management,
complaint handling, audits, inspections, Corporate Compliance, Product Pricing, Human Resources, Benefits system,
planning, scheduling, procurement, team building, cross functional teams, multi-site management, wound care, medical
device, powered and non-powered medical device, software and non-software medical device, electrical and non-electrical
medical device, salesforce.com, pharmaceutical, CAPA, Corrective action, preventive action, preventive maintenance,
corrective maintenance, calibration, periodic maintenance, scheduled maintenance, scheduled calibration, timelines,
Capital asset management, Medical Device Manufacturing & Quality Assurance Consultant, stents, coated stents, balloon
catheters, diagnostic catheters, PET trays, Guide wires,
Awards & Certifications
Performance Awards (1982³, 1983, 1984², 1985³,1990, 1991, 1992², 1995, 1996², 2006)
Technical Awards (1982², 1983, 1985, 1986,1996)
Team Excellence Awards (2001², 2002)
J&J Leadership Award (2004)
J&J Achievement Awards (1998², 1999)
US Patent # 5,897,497 (1999)
Six Sigma Green Belt Certification – Harrington Institute (2003)
Six Sigma Process Champion Certification – Harrington Institute (2008)
Safety and Ergonomics – National Safety Council of South Florida (2007)
Design of Experiments – Air Academy Associates (1998)
Management Skills for Engineers – University of Florida (2000)
Project Management – SoftKey PM University (2008)
Associations
South Florida Manufacturing Association – Member of Board of Directors
Education
Florida International University, Miami, Florida; Graduated; (ongoing)
Masters of Science Degree in Engineering Management
Nova Southeastern University, Broward County, Fl.; Graduated 1997
Bachelor of Science Degree Business Management
Florida International University, Miami, Florida; Graduated; 1989
Bachelor of Science Degree in Mechanical Engineering
Clinton Community College – Plattsburg NY; Graduated 1984
College Prep Course
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Juan C Fernandez
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Resume of
Juan C Fernandez

jcfresume2015MFG

  • 1.
    Juan C. Fernandez 1374SW 159th Lane Pembroke Pines, Florida 33027 954-885-0404 (H) 954-536-3220 (C) fern5407@bellsouth.net LinkedIn shortcut; https://www.linkedin.com/profile/public-profile-settings?trk=prof-edit-edit-public_profile A “hands on”, results oriented, professional with over 29 years of experience managing high performance teams in such areas as Manufacturing Operations. Other areas of responsibility included Quality Assurance, Risk Management, Complaint Handling, Regulatory Affairs Customer Service Warehousing, Distribution, Product, Process & Manufacturing engineering, Manufacturing (in-house and contract), Order and procurement Planning, Project management, Environmental Health & Safety, Human resources, Finance & Facilities and Equipment Maintenance Management roles in the medical device, pharmaceutical & automotive industry. I am also a Certified Six Sigma Green Belt & Process Champion. I employ a team-based, leadership style, which encourages & promotes innovative risk taking, continuous improvement, career development & a skill-learning environment. I am a problem solver, with particular strengths in managing crisis & turn around situations, as well as identifying & maximizing on opportunities. The values I bring to your organization are: Business skills and Ownership; A technical leader; with demonstrated strengths in managing technical and non-technical resources to achieve organizational, product build and launch objectives. Management style provides mentoring & guidance while instilling an environment for achievement & development. Creating common objectives & standards, coordinating, leading, training & leveraging cross functional teams (Mfg., PD, QA, S&M, EHS, Facilities, sales & marketing) operating both locally & at international sites; Developed Project management operations and systems required to run and sustain the business. Developed manufacturing strategies / plans targeted at increased revenue and business growth. Met quarterly with Board of Directors. Quality Assurance & Regulatory Designated as the site representative and point of contact for inspection agencies such as FDA, OSHA, EPA, TUV, DQS, BSI, FCC, TUV, ETL. Emergo. In addition was also familiar with requirements for such agencies as AHCA, JCAHO (TJC), NFPA, ADA, HRS. Monitor performance metrics as well as survey agencies in industry for regulation changes. Financial Accountability; Accountable for Department and organizational P&L, site capital budget, product costing, sales forecasting and demand planning, schedule performance, project timelines, cost of quality measures, capital asset management, & inventory levels. Continuous improvement; Certified Lean Six Sigma Green Belt & Process Champion, as well as Environmental, Health and Safety lead. Fostered a success oriented, cost sensitive environment. Developed and motivated high performance management team. Established business performance targets and reviewed metrics monthly with Sr. Mgmt. team and quarterly with Board of Directors. Functional exp. / Skills; Project management, Manufacturing, Procurement, Distribution, warehouse, Engineering (process, Manufacturing, Product, software, facilities), Environmental Health & Safety, Risk Management, Human Resources, Corporate Compliance, Customer Service center, Facilities management & Quality Assurance (supplier, Manufacturing, Product development, In house QMS), Regulatory, budgeting, mentoring, coaching, computer / software literate. Project management; Experience projects leader of various program types (product / process development, facilities, Mfg., QA & Regulatory) budgeted & valued in excess of Millions of dollars. Establish user requirements, developing timelines & budgets, managing resources & communicating status. Work with project teams to identify activities / task, risk & their contingencies, resource planning, timeline generation; hold project teams accountable & provide continuous feedback to team members in terms of significant changes in direction or performance. Ability to effectively work & communicate with members of various functional teams throughout organization and communicate status updates to Sr. Management team as well as Board of Directors. Participate in development of global strategic & tactical objectives. As an experienced professional within your organization, I would deliver results through such talents as leadership, communication, program management, financial planning & team building. Page 1 of 8 Resume of Juan C Fernandez
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    Juan C. Fernandez 1374SW 159th Lane Pembroke Pines, Florida 33027 954-885-0404 (H) 954-536-3220 (C) fern5407@bellsouth.net Professional Experience MEDDEVICE Manufacturing Solutions, LLC. Dec. 2014 to Present Professional turnkey consulting service specializing in manufacturing and associated logistics for Medical Device Companies. Manage day to day activities related to business operations. Provide specialized services to clients requesting assistance in establishing / optimizing medical device manufacturing process and logistics. Other areas classified as logistics include, supplier sourcing, procurement, warehouse inventory, distribution, forecasting, budgeting, manufacturing team sourcing (technical and non-technical), Project Management, Quality Assurance, Regulatory, Environmental Health and Safety, Facilities Management, Risk Management, Corporate Compliance, Human Resources, Engineering (product, process, software, and manufacturing). Agencies which I communicate with include FDA, OSHA, TUV, DQS, UL, FCC, ETL, Emergo. Significant Achievements / services provided include; Manufacturing / Operations Medical Device Sterilization Process & Control, Sterilization & Re-sterilization of Medical Devices Support functions within medical device companies, Sterilization and tracking of product Supplier / Procurement Develop & implement Contract Manufacturer / supplier system which included contractor / supplier identification and assessment program, Medical Device Mfg. / MRO Supplies Sourcing Quality Assurance& Regulatory Medical Device Crisis & Risk Management, Perform QMS system audits and feedback, .Provide outlines of requirements for sustainable & compliant QMS system; establish QMS and regulatory systems as required for specific products manufactured. Facilities Manager Provide guidance on waste management requirements as required per EMS 14001 Environmental Health & Safety Guide with establishing OSHA Safety programs as per OSHA CFR29 (Programs such as such as Lockout tag- out, forklift safety, Personal protective equipment, ect), Establish waste material disposal process as per EMS 14001, Establish OSHA log tracking and reporting system. Human Resources Internal vs. External HR support Director of Operations Vossen Wheels Inc. July 2014 to Feb. 2015 Designer & manufacturer of aftermarket wheels for high end automobiles Spear head day to day activities with oversight of resources (engineering, manufacturing, supply chain (procurement, inventory management, manufacturing, warehousing, distribution) sales marketing, and Quality assurance in ensuring we deliver the correct ordered product in a timely manner, while ensuring the upmost quality. Manage facilities and maintenance program; address planned and unplanned audits (TUV, OSHA, DERM,); I manage a team of 47 resources. I hold monthly Sr. Mgmt. team meeting; Established “operations”, Engineering, Project Management and Quality Systems from ground up; additional responsibilities include, staffing, customer service, Product Development Engineering, Environmental Health & Safety, Responsible for both internal and external manufacturing and supplier resources and activities. Significant Achievements include; Manufacturing / Operations First manufacturing builds / new mfg. line in 3 weeks from employment start date; Re-aligned mfg. & Eng. to maximize sales order deliveries; Initiated Sales Ops Mtg.; Implement Capital & Expense budget sheet; Implement performance metrics; Established Manufacturing schedules & inventory management tracking; Supplier / Procurement Develop & implement Contract Manufacturer / supplier system which included contractor / supplier assessment program, Establish procurement / Invoice program which aimed at (1) price reduction (2) systemize method of Page 2 of 8 Resume of Juan C Fernandez
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    procuring materials; ensuretimely payment of invoices. Customer Service Established Customer & technical service support system, Established metrics tracking for complaint calls. Engineering & Project Management Established project management program to drive projects from R&D to launch, This also entailed project progress tracking method, cost tracking and customer feedback process; Identified and incorporated necessary engineering tools (IE computers and software) required; Identified necessary training for engineers so as to acquaint them with the software used to generate designs and software for the manufacturing machine. Quality Assurance& Regulatory Established documentation control system to manage revision controlled documents and programs; Implement receiving inspection process; Implemented complaint and product return process; Implement Risk Management program; Instituted design verification method for product (FEA); Acquired TUV certification allowing for distribution outside of US. Facilities Manager Managed site related facility modifications; Managed county & state inspection and permit agencies; Worked with contractors to ensure installation of equipment and utilities and other facility related requirements; Was point of contact for utility companies. Environmental Health & Safety Established Safety programs as per OSHA CFR29 (IE; Lockout tag-out, forklift safety, Personal protective equipment, ect); As per ISO 14001, establish waste material pickup, disposal & manifest system. Human Resources Instituted Hiring agreements. Developed job Descriptions, interviewed candidates and extended job offers. Established benefits package for hew hires & existing employees; Develop Salary scale; Develop Performance Assessment process; Worked with Dept. of Labor to establish worker’s identities (exempts vs non exempts) & over time requirements as well updated internal policies on new laws and requirements (IE FMLA); Served as HR representative so as to address questions and or communications to employees. C.O.O. / Exec. VP Operations / Corporate Compliance Officer, Orthosensor Inc. Feb. 2011 to June 2014 Start up medical device organization; Developer & manufacturer Intelligent Orthopedic Medical devices used during Total Knee Replacement Surgery. Very “hands on role”; Lead establishment of “operations systems” from ground up with a focus on Manufacturing, Quality Assurance & Regulatory, Product Development Engineering and project management process. Established in compliance with FDA ISO 13485 so as to endure design controls and traceability. Developed project timeline outlines, manpower, work flow and financial analysis reports. Additional responsibilities included staffing, Supply Chain, Customer & technical Service, Facilities Management, Environmental Health & Safety and Corporate Compliance program. Accountable for department strategies, and budgets. Active participant of the board of Directors. Designated site management representative for all internal / external audit agency / compliance related activities which included FDA, EPA, OSHO, TUV, DQS, BSI, FCC, UL, Emergo, AHCA, JCAHO, NFPA, ADA, HRS. Significant Achievements include; Quality Assurance & Regulatory Management representative for all federal and local agencies; Obtained certification to FDA ISO 13485 in less than 4 months; Established Mfg. & QA regulatory KPI / Metrics; Established a paper-less documentation control system per FDA requirements; also established requirements for Software used in conjunction with product; Passed FDA initial site inspection (0 Major Observations); Passed 3rd Party (DQS) ISO 13485 re-certification inspection; 0 Observations; Established Risk Management process (as per ISO 14971) which included Complaint handling, product return, failure analysis process, CAPA system and product surveillance; Established Site Operation contingency plan; Established Product development QAE support system; Aligned internal requirements with those of AHCA, JCAHO, NFPA, ADA, HRS so as to ensure compliance when equipment was rolled out to hospitals. Manufacturing Operations Established necessary systems, relationships & expectations for Contract Manufacturers & suppliers. Establish procurement / supplier program which aimed at price reduction & optimization of procured components & materials as well as on time deliveries; Establish internal Product receiving, warehouse & distribution system; Established manufacturing schedule & inventory management tracking systems; Established Sales Ops Mtg. for collaboration & communication between Ops, Sales, Marketing & finance team members; Established Customer & technical service support system; Established Capital & Expense budget sheet for use by organization. Engineering & Project Management Delivered Generation I, Class II Electronic Medical Device, with software, to market in under 8 months; Page 3 of 8 Resume of Juan C Fernandez
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    Establish site projectmanagement system used to track and report status of projects from R&D to launch; Established Design control process / system for engineering management / design phase control of programs; Utilized Contract injection molding firms for design and manufacturing of products. Two sites established as a contingency; Formalized Design control system so as to include 6 phases (1.Mgmt Approval, 2 Feasibility 3. Development 4. Validation Implementation 5. Launch 6. Post Market Surveillance). Facilities Management Sustaining & expansion efforts of building & equipment; Site representative for local agency (Fire, OSHA, EPA, county and State) inspections; Environmental, Health & Safety Establish Environmental Health & Safety Programs as per OSHA CFR 29; included chemical storage, waste disposal, & manifest management; Also included safety prevention programs for sales, office & technical team; Developed and deployed necessary safety training to relevant members; Human Resources Developed job Descriptions, interviewed candidates and extended hire agreements; Instituted benefits & training program for hew hires & existing employees; Worked with Dept. of Labor to establish worker’s identities (exempts vs non exempts) & over time requirements; Developed and established electronic training tracking system; Served as point of contact for employees with regards to HR policies. Finance Instituted initial Budget system; included capital asset mgmt. system; Instituted ERP system to track sellable inventory and components; Implemented Contract development / approval process for all functional areas (IE Supply chain. Clinical trials, Manufacturing, Contract employees, ect.) Risk Management & Corporate Compliance Implemented Corporate Compliance Program as per the Office of Inspector General. Wrote procedures and policies for the segments of Risk Management and provided training to entire work force. Sales Developed initial sales forecast along with members of Product development, marketing and finance. Identified and introduced organization to Salesforce.com Vice President Engineering, Tridien Medical March 2010 to February 2011 Developer & manufacturer of powered (with electronics and software) & non powered support surfaces & positioners for wound care management. Responsible for technical and manufacturing operation of two sites (Florida 7 California). Responsible for staffing, budgeting (Expense, sales & capital), Strategic business planning, active participant with Board of Directors, equipment and facilities maintenance, environmental health and Safety, and manufacturing technical needs. Establish business partnerships with customers as well as supplier. Work with in-house functional departments to set and align objectives and projects. Established in house project management program to ensure tracking and reporting of projects. Worked closely with QA during generation / updates of submission to FDA for product approval as well as with incorporation of new regulatory mandates. Worked with external resources / contractors to balance internal project load as needed. Significant Achievements include; Engineering & Project Management Restructure engineering teams at both sites to streamline process & optimize; Establish R&D / Eng. Inventory management system & warehouse for non-stock items; Establish Engineering project / program management system to include timeline design, manpower analysis, work flow structure and project status reports; Established Engineering technology forum to discuss updates, new technologies, and for leveraging of technologies across business; Established system for working with contractors on outsourced portions of projects; Environmental, Health and Safety; Institute site Safety program as per OSHA CFR 29; included chemical storage, waste disposal, & manifest management, Also included safety prevention programs for sales, office & technical team; Developed and deployed necessary training related to Safety programs for Sales, Engineering and Quality assurance. Manufacturing Operations Establish new business conduit for distribution of product; Established product training forum for sales team; Established customer feedback system for preliminary input of new products; Established Mfg. & Engineering performance KPI / Metrics; Established detailed Capital & Expense budget sheet for use by entire organization; Established performance schedule & inventory management tracking systems; Established employee training / job rotation program; Established Self-Managed Improvement Teams in Mfg. Quality Assurance and Regulatory Established documentation control system for engineering drawing / documentation; Reduce overdue Engineering CAPA log by 100% in 90 days; Established Risk Management program; Aligned internal product requirements with those of AHCA, JCAHO, NFPA, ADA, HRS, FDA, UL, FCC so as to ensure compliance to Page 4 of 8 Resume of Juan C Fernandez
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    agency and hospitalrequirements. Incorporate risk management program as part of engineering design controls. Director of Engineering, Noven Pharmaceutical, Inc. June 2005 to March 2010 Developer &, manufacturer of transdermal Transmucosul drug delivery systems. Managed engineering organization with a high emphasis on manufacturing and project management. Additional responsibilities included Calibration, Maintenance, Environmental Health & Safety, Manufacturing, Process and industrial Engineering technology teams and manufacturing efficiencies and schedule obtainment. Responsibilities include staffing, budgeting, establishing department goals & managing crisis as they occur. Establishing & sustaining supplier & vendor partnerships. Work with in-house functional departments to ensure timely completion of all product & or process engineering related projects / programs. Work with Manufacturing to ensure timely resolution of issues as they arose as well as to improve mfg. metrics. Also work to keep mfg. technology up to date. Lead efforts related to transfer of technology between R&D & manufacturing as well as between manufacturing sites. Managed Mfg. / operations department comprised of over 200 direct labor personnel (2 shift operation). Significant Achievements include; Lean Six Sigma Methodology Implemented Lean Six Sigma methodology at site; Certified all members of engineering organization; Lean Six Sigma Process Champion & Green belt Certified; Maintenance & Calibration & Facilities Management Re-Structured calibration & maintenance system; achieved 0 overdue; No major audit observation related to internal & external system audits; Along with facilities team, implemented procedure which manage contractors through various manufacturing area expansions projects; Awarded achievement award for facility readiness during Hurricane seasons. Environmental Health & safety Enhanced site safety program with additions of various programs; Lock Out, Tag Out & Zero Access Equipment guidelines; Enhanced site safety program with the addition of DuPont’s S.T.O.P.; Achieved 0 Incident levels for Major and minor accidents for a period of 12 months. Manufacturing Operations Reduced total monthly equipment related down from 600 hrs. to 123 hrs.; Equipment Troubleshooting Guides decreased machine down time by >75%.; Instituted Technician & Lead Machine Operator OJT program; decreased down time by >75%.; Introduced new transdermal pouching & packaging Mfg. Lines. Instituted Mfg. downtime tracking system; Instituted Self-Managed Improvement teams within operations & mfg.; generated savings of >150K; Through redesign efforts, decreased the cost of machine fabrication by over $400K; Instituted O.E.E. system with ability to view live updates via computer work stations in offices; Instituted business development costing model for new product; Participated in Business development activities related to new opportunities; Program Manager during transfer & scale up of product line located in California. Engineering and Project Management Formalized Project management process with specific timeline designs and incorporation of work and manpower reports; Instituted R&D and manufacturing transition process for transfer of product from R&D to manufacturing; Instituted technology forum for discussion of upgrades & new technologies (product and Process); Worked with Regulatory to update NDA / ANDA as required; Instituted OEE system viewable from office desk; Decreased design & fabrication cost of converter lines by $400K; Introduced Allen Bradley controller systems across all mechanized process. Director of Quality Assurance, VeinRX Inc. Feb 2005 to June 2005 Start up organization; Developer / manufacturer of medical devices for minimally invasive vascular (Varicose) disease management Head of Quality Assurance/ Regulatory and designated Site management representative for all agency related audits / activities (IE; TUV, BSI, OSHA, EPA, FDA, FCC, UL). Responsibilities also included managing project/ timeline management of new Quality Systems integration and new product development and introduction, supporting product development initiatives, generating documentation, providing support to Manufacturing team and to clinical research team, the generation / updating of Submissions to FDA for product release approval, development of project & manufacturing strategies, departmental goals & budgets, completion of facilities related work, calibration & preventive maintenance on equipment and Environmental Health and Safety. Responsible also included the investigation & resolution of all technical issues related to product & manufacturing processes, CAPA system requirements, Risk Management, Resource screening, hiring and assessing and complaint handling. Coordinated with members of Product Development, R&D, Operations, Quality, Planning, Finance, Human Resources and Marketing & Sales to develop strategic goals for organization. Significant Achievements include Quality Assurance & Regulatory Developed & implemented site wide QMS system compliant to ISO 13485; Achieved 13485 certification for site in less than 6 months; Established company Electronic (paperless) Doc control System; Established & ran Page 5 of 8 Resume of Juan C Fernandez
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    clinical trials systemwhich included being present in clinical setting. Managed & tracked all pertinent clinical outcomes; Established Risk Management / product surveillance & Complaint handling program; Generated 510K submissions to FDA. Acquired approval in less than 3 months as I was able to make submission a Special 510K;Established & enforced QMS system & requirements for site; included CAPA system & complaint management system; Environmental Health and Safety Established OSHA safety program as per CFR 29 across site; This included establishing process for disposal of engineering and manufacturing waste generation. Engineering and Project Management Established procedure for project management system which included timeline, resource reports and set meeting for updates; System was setup to also ensure compliance to ISO 13485’s design controls requirements. Engineering / Operations Manager, Cordis Corp.; Jan 1988 to Feb 2005 Developer &, manufacturer of medical & combination devices for minimally invasive Cardio, Neuro & Endo vascular disease management Managed Engineering & operations team ( manufacturing engineering, manufacturing, planning, procurement, Quality Assurance & facilities) assigned to Business unit; Overall duties included project/ timeline management of new process / product introduction, manufacturing improvements, development of project & manufacturing strategies focused on business growth, development of departmental goals & budgets, planning / execution of weekly production schedule demand, inventory goals, the completion of facilities related work, & calibration & preventive maintenance on equipment. Also responsible for investigation & resolution of technical issues related to the manufacturing processes / product as they arose or were reported back from customers. Responsible for department’s Quality program (CAPA, Complaint management & yield metrics). Coordinated with members of Product Development, R&D, Operations, Quality, Planning, Finance, Human Resources, Marketing & Sales to develop short and long term goals for Business Unit. Significant Achievements include; Lean Six Sigma Lean Six Sigma Process Champion; Saved $150K. Certified 100% of technical team to Six Sigma mythology. Manufacturing Operations Weekly mfg. schedule performance above 98% consistently; Managed 130 employees; Sales Operations effort to discuss KPI’s, new opportunities & filed challenges. Engineering & Project Management Supported transfer of manufacturing process to OEM as well as other J&J sites; Realized a $350K annual savings by optimizing joint fusing process; Reduced crimp band failure by 25%; Eliminated pin hole failures on stented balloon catheters; 30% to 0%.; Re-established project management process ensuring consistency in information and method which information was reported. Environmental Health & Safety Monthly training of team members on Health & Wellness, Safety practices & Quality Regulations; Also responsible for training of employees on new process. Process Champion /Site Compliance Prjt. Mgr., Cordis Corporation; Sept 2004 to Jan 2005 Developer &, manufacturer of medical & combination devices for minimally invasive Cardio, Neuro & Endo vascular disease management Lead site compliance efforts of three Johnson & Johnson, Cordis sites; (Puerto Rico, Juarez, Mx. & Miami, Fl.) Responsible for assigning & managing resources at each site with which to execute action plan(s) aimed to address FDA observations. Established monitoring & reporting system used to keep Johnson & Johnson Sr. Management members & FDA abreast of progress of activities. Also lead preventive measure activities focused on avoiding the future reoccurrences of similar observations. Reported to W.W. VP of Quality Assurance. Significant Achievements include; Quality Assurance Addressed over 50% of all observations in 90 days; FDA removed warning letter based on compliance effort results; Institution of CAPA system which ensured effectiveness prior to closure; Established Risk Management / product surveillance & optimized Complaint handling program; Held monthly mtg. with Sr. team; Process / Product Development Eng. (Contractor); Scion Cardiovascular; Feb 2004 to April 2004 Developers and designers of devices used in managing cerebral aneurisms. Project manager responsible for the establishment and scale up of manufacturing process. Worked in conjunction with QA, Regulatory and engineering to ensure manufacturing readiness for engineering, validation and initial shelf stock quantities. Page 6 of 8 Resume of Juan C Fernandez
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    Other positions heldat Cordis; Process Engineering Manager, Cordis Corp. Endovascular Division 2003 to 2004 Manufacturing / Process Development Lead Engineer (Cardiology) 1995 to1996 Product Development Engineer (Cardiology) 1993 to 1995 Product Performance / Complaint Lab Technician 1986 – 1988 Aircraft Maintenance / Special Operations Team member U.S. Air Forces 1982 - 1988 Responsible for 22 assigned aircraft as well as management & development of 55 airmen. Member of Air Force Special Operations Tactical Teams; SRT Significant Achievements included; Honorably Discharged Several Service awards obtained (Achievement, Commendation, Longevity, Distinguished Unit) Specific Skills Leadership, management, Inventory management, Supply Chain, Quality Assurance, Manufacturing, Six Sigma, Facilities Management, Green Belt, Process Champion, Computer literate, word, excel, PowerPoint, Visio, MSproject, software validation, product validation, product development, project management, process validation, design of experiments, DOE, FDA, ISO, 13845, CFR 29, Environmental Health and safety, OSHA, EPA, EMS 14001, AHCA, JCAHO, NFPA, ADA, HRSA mentoring, problem solving, budgeting, finance, strategy, supplier management, warehousing, distribution, contractor management, training, Statistical Process Control, regulatory, Regulatory submission, Risk Management, complaint handling, audits, inspections, Corporate Compliance, Product Pricing, Human Resources, Benefits system, planning, scheduling, procurement, team building, cross functional teams, multi-site management, wound care, medical device, powered and non-powered medical device, software and non-software medical device, electrical and non-electrical medical device, salesforce.com, pharmaceutical, CAPA, Corrective action, preventive action, preventive maintenance, corrective maintenance, calibration, periodic maintenance, scheduled maintenance, scheduled calibration, timelines, Capital asset management, Medical Device Manufacturing & Quality Assurance Consultant, stents, coated stents, balloon catheters, diagnostic catheters, PET trays, Guide wires, Awards & Certifications Performance Awards (1982³, 1983, 1984², 1985³,1990, 1991, 1992², 1995, 1996², 2006) Technical Awards (1982², 1983, 1985, 1986,1996) Team Excellence Awards (2001², 2002) J&J Leadership Award (2004) J&J Achievement Awards (1998², 1999) US Patent # 5,897,497 (1999) Six Sigma Green Belt Certification – Harrington Institute (2003) Six Sigma Process Champion Certification – Harrington Institute (2008) Safety and Ergonomics – National Safety Council of South Florida (2007) Design of Experiments – Air Academy Associates (1998) Management Skills for Engineers – University of Florida (2000) Project Management – SoftKey PM University (2008) Associations South Florida Manufacturing Association – Member of Board of Directors Education Florida International University, Miami, Florida; Graduated; (ongoing) Masters of Science Degree in Engineering Management Nova Southeastern University, Broward County, Fl.; Graduated 1997 Bachelor of Science Degree Business Management Florida International University, Miami, Florida; Graduated; 1989 Bachelor of Science Degree in Mechanical Engineering Clinton Community College – Plattsburg NY; Graduated 1984 College Prep Course Page 7 of 8 Resume of Juan C Fernandez
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