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Scott MacLean
9555 NW Highway 25  Ocala, FL 34482  352.875.7932  smaclean2006@yahoo.com
Positions held:
Plant Manager / Director of Operations / Quality Director / Quality Manager / Quality Engineer / Production Manager / Maintenance Manager
A highly regarded, well-qualified, dedicated, and results-driven management-level professional with 27 years of multi-faceted manufacturing
experience, including 19 years as a Quality Director or Quality Manager, and 9 years in senior management roles. Scott is a superior
communicator - adept at creating and fortifying strategic partnership with peers, management teams, executive stakeholders, and outside
agencies. Seeking new opportunities with a forward-thinking company that values growth, professional development, and that encourages
innovative thinking.
CORE COMPETENCIES
Statistics  Quality Systems  Certified ISO 13485 Lean Auditor  AS9100/AS9101 Lead Auditor  Certified Lean Manufacturing – Kaizen,
Certified Lean Six Sigma Greenbelt, GMP, TQM, HACCP, AIB, IQ, OQ, PQ  GD&T  Cleanroom monitoring Microsoft Office Suite  FileMaker
Pro programming  ASQC Certified - Mechanical Inspector  Quality Technician  Machine Fanuc Control Programming  CMM Operator
Programmer  Hardness Inspection  Metrology  Calibration Systems  Quality Management  Strategic Planning  Manufacturing
Production Scheduling/Control  Inventory/Materials Management  Project Development  Warehousing  Distribution 
Budgeting/Finance  Human Resources  Capital Improvements  Teaching/Coaching  ISO Implementations  Quality Policy Design 
Control Plans  Quality Auditing  Equipment Calibration  Customer Relationship  Program Management  Leadership  Full SPC tool
box, including but not limited to: DOE, GR&R, Sampling Pans, Control Charts, 8D, Fishbone, Pareto Analysis etc.
EXPERIENCES AND ACHIEVEMENTS
Metro Steel & Pipe Supply, Inc., Tavares, FL 2015 –Present
Metro Steel is a major supplier of steel and pipe.
Fabrication facility with Laser, Plasma, Brakes and Machine shop that supports the welding and fabrication supporting the
industrial, commercial and aerospace industries
Quality Director
I was hired to establish a new QMS system, in line to the requirements of ISO 9001: 2015, with the goal to become certified by October 2016.
Implement processes through the Plan, Do, Check, Act cycle (PDCA) with a focus on risks. Direct the implementation/maintenance of all
controlled documents.
Develop a LeanManufacturing environment through 5s, implementationof control plans, Issue monitoring, Continuance Improvement activities,
SIPOCs, FEMAs, APQP, Metrology etc.
Developing an analysis platform to monitor the company’s performance including internal/external discrepancies, calculating actual PPM to
goals, and Pareto analysis of discrepancies, causes, dispositions, CAPA’s, on-time deliveries, customer satisfaction surveys, continuous process
improvement activities, Internal audits and reports of previous action items.
VETERANS TRADING COMPANY (VTC), Ocala, FL 2015
Military Procurement Company serving Major USA Defence Contractors
ISO 9001,AS9100 and AS6081 Certified
Quality Engineer/Specialist III/CAPA Lead, Lead Internal Auditor, Certified LSS Greenbelt
Providesupervision and guidanceto Lead Quality Specialists. Responsiblefor thecompany’s Correctiveand PreventiveAction (CAPA) activity and interactdaily with
customers) and sub-tier suppliers to facilitate the process. Support theorganizations internaland externalproblem resolution activities to resolveproduct and
processing quality issues while enhancing customer satisfaction. Accountablefor overseeing non-conformances issues including containment, disposition, root
cause analysis and corrective actions. I was responsiblefor allinternal and externalaudits. Createaudit support documentation and coordinatewith customers,
suppliers, and 3rd party auditors during auditing activities.
Selected Contributions:
 VerifyFirst Article Inspections from suppliers; review/inspect first article documentation(FAI) prior to customer submittals for accuracy
and completeness.
 Schedule, facilitate and conduct AS9100/AS9120 internal audit process as defined by AS9100/AS9120/AS9101 guidelines.
 Responsible for calibration tasks including scheduling and maintaining organizational equipment calibration management facilitation
and records.
 Facilitate/maintain the company’s customer and sub-tier supplier GIDEP notification process.
 Manage document control and quality trend analysis.
SCOTT MACLEAN Resume, Page 2
Professional Experience, continued
NANOTECHNOVATION CORPORATION (dba CLAIRSON PLASTICS), Ocala, FL 2011 – 2014
Medical Device Company serving Major USA Medical Contractors
Certified ISO 13485 Lead Auditor; Certified LSS Greenbelt; ISO Representative; FDA Representative
Quality Assurance Manager
Accountable for monitoring medical device regulations. Demonstrated expertise in Quality Systems ISO 9001 & 13485; certified ISO 13485 Lead
Auditor with more than 23 years of implementing ISO 9000 Quality Systems. Scheduled and oversaw annual management meetings. Supplied all
analysis pertaining tothe company’s performance including internal/external discrepancies, calculating actual PPM to goals, and Pareto analysis
of discrepancies, causes, dispositions, CAPA’s, on-time deliveries, customer satisfaction surveys, continuous process improvement activities, and
reports of previous action items. Served as the Lean Manufacturing advisor; responsible for the company’s FDA compliance. Led SPC, FMEA,
APQP, CAPAs, Metrology, Cleanroom monitoring and product process control plans. Directed the implementation/maintenance of all controlled
documents.
Selected Contributions:
 Managed all functions of the Quality Control and Quality Assurance activities including inspection, calibration, MRB, customer
complaints, statistical process control applications, and validations (IQ, OQ, PQ, PV).
 Oversaw company training records and assisted with training development. Trained all employees in QMS; conducted new employee
orientations.
 Collaborated with Manufacturing to create product specifications that defined processes and inspection requirements for each
product.
 Participated in the quotes process; evaluated capabilities and FDA requirements.
 Reviewed and approved all supplier quality agreements.
 As a Certified ISO 13485 Lead Auditor, implemented, trained, and oversaw all internal auditors and internal audit activities; including
Internal Auditor training. Represented the company to customers and to the Registrar.
 Reduced third party ISO audit findings from six in 2011 (2 majors 4 minors) to zero in 2013.
MACLEAN’S EXQUISITE DESIGNS, LLC, Ocala, FL 2010 – Present
Design, Patent and Market uniqueproducts Company
Owner
NATIONAL FRUIT PRODUCT COMPANY, Lincolnton, NC 2004 – 2010
Production/Maintenance Manager
Completed additional duties as the Acting Plant Manager. Completed project team planning to install a 750 BPM PET bottling line. Partnered with
Pepsi and their suppliers to meet production and quality demands. Developed preventative/predictive maintenance programs; oversaw all plant
requisitioning and capital expenditures. Implemented multiple improvement programs including Lean Manufacturing, a work order program that
identified areas of concern and immediately assigned resolution/corrective action. Oversaw HACCP, GMP, Calibration, and all plant operations.
Selected Contributions:
 Instrumental in helping the company became the national Gatorade co-packer, with the lowest number of customer complaints.
 Discovered, through data analysis and testing, that the supplied PET bottle was out of specifications, causing a high reject rate for
cocked caps. Instrumental in correcting the issue.
 Personally developed database to monitor all on-going projects and production scheduling.
 Achieved a 13% increase inmonthly revenue over 18 months.
 Achieved the highest QSA (Pepsi qualityaudit) score andthe highest AIB (AmericanInstitute of Baking) score in this plant’s history.
 Reduced PM and CIP activities from 8 hours to 4 hours; a 50% reduction.
Additional experience as a Business Owner of RyDan Precision, Inc. (manufacturing); Director of Operations with Lakeside Precision (manufacturing);
President of MacLean Technologies (Quality Management) ; and Inspection/Calibration Supervisor with Moog Contr ols.
EDUCATION AND TRAINING
Quality Engineering and Statistics, Canisius College, Buffalo, New York,
Certified ISO 13485 Lead Auditor, ORIEL STAT A MATRIX
Certificate in Certified LSS Greenbelt; Microbiology, Purdue University
Certified Mechanical Inspector; Certified Quality Technician, American Society of Quality Control
AS9100 Quality Management Systems, Requirements for Aviation, Space and Defense Organizations
AS6081 Fraudulent/counterfeit Parts, Avoidance, Detection, Mitigation, and Disposition
Metrology, Gage design, R&R studies, CMM programing, GD&T
Validations, OPQ, IPQ, PPQ, PV, APQP

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maclean--scott---resume 1-19-2016

  • 1. Scott MacLean 9555 NW Highway 25  Ocala, FL 34482  352.875.7932  smaclean2006@yahoo.com Positions held: Plant Manager / Director of Operations / Quality Director / Quality Manager / Quality Engineer / Production Manager / Maintenance Manager A highly regarded, well-qualified, dedicated, and results-driven management-level professional with 27 years of multi-faceted manufacturing experience, including 19 years as a Quality Director or Quality Manager, and 9 years in senior management roles. Scott is a superior communicator - adept at creating and fortifying strategic partnership with peers, management teams, executive stakeholders, and outside agencies. Seeking new opportunities with a forward-thinking company that values growth, professional development, and that encourages innovative thinking. CORE COMPETENCIES Statistics  Quality Systems  Certified ISO 13485 Lean Auditor  AS9100/AS9101 Lead Auditor  Certified Lean Manufacturing – Kaizen, Certified Lean Six Sigma Greenbelt, GMP, TQM, HACCP, AIB, IQ, OQ, PQ  GD&T  Cleanroom monitoring Microsoft Office Suite  FileMaker Pro programming  ASQC Certified - Mechanical Inspector  Quality Technician  Machine Fanuc Control Programming  CMM Operator Programmer  Hardness Inspection  Metrology  Calibration Systems  Quality Management  Strategic Planning  Manufacturing Production Scheduling/Control  Inventory/Materials Management  Project Development  Warehousing  Distribution  Budgeting/Finance  Human Resources  Capital Improvements  Teaching/Coaching  ISO Implementations  Quality Policy Design  Control Plans  Quality Auditing  Equipment Calibration  Customer Relationship  Program Management  Leadership  Full SPC tool box, including but not limited to: DOE, GR&R, Sampling Pans, Control Charts, 8D, Fishbone, Pareto Analysis etc. EXPERIENCES AND ACHIEVEMENTS Metro Steel & Pipe Supply, Inc., Tavares, FL 2015 –Present Metro Steel is a major supplier of steel and pipe. Fabrication facility with Laser, Plasma, Brakes and Machine shop that supports the welding and fabrication supporting the industrial, commercial and aerospace industries Quality Director I was hired to establish a new QMS system, in line to the requirements of ISO 9001: 2015, with the goal to become certified by October 2016. Implement processes through the Plan, Do, Check, Act cycle (PDCA) with a focus on risks. Direct the implementation/maintenance of all controlled documents. Develop a LeanManufacturing environment through 5s, implementationof control plans, Issue monitoring, Continuance Improvement activities, SIPOCs, FEMAs, APQP, Metrology etc. Developing an analysis platform to monitor the company’s performance including internal/external discrepancies, calculating actual PPM to goals, and Pareto analysis of discrepancies, causes, dispositions, CAPA’s, on-time deliveries, customer satisfaction surveys, continuous process improvement activities, Internal audits and reports of previous action items. VETERANS TRADING COMPANY (VTC), Ocala, FL 2015 Military Procurement Company serving Major USA Defence Contractors ISO 9001,AS9100 and AS6081 Certified Quality Engineer/Specialist III/CAPA Lead, Lead Internal Auditor, Certified LSS Greenbelt Providesupervision and guidanceto Lead Quality Specialists. Responsiblefor thecompany’s Correctiveand PreventiveAction (CAPA) activity and interactdaily with customers) and sub-tier suppliers to facilitate the process. Support theorganizations internaland externalproblem resolution activities to resolveproduct and processing quality issues while enhancing customer satisfaction. Accountablefor overseeing non-conformances issues including containment, disposition, root cause analysis and corrective actions. I was responsiblefor allinternal and externalaudits. Createaudit support documentation and coordinatewith customers, suppliers, and 3rd party auditors during auditing activities. Selected Contributions:  VerifyFirst Article Inspections from suppliers; review/inspect first article documentation(FAI) prior to customer submittals for accuracy and completeness.  Schedule, facilitate and conduct AS9100/AS9120 internal audit process as defined by AS9100/AS9120/AS9101 guidelines.  Responsible for calibration tasks including scheduling and maintaining organizational equipment calibration management facilitation and records.  Facilitate/maintain the company’s customer and sub-tier supplier GIDEP notification process.  Manage document control and quality trend analysis.
  • 2. SCOTT MACLEAN Resume, Page 2 Professional Experience, continued NANOTECHNOVATION CORPORATION (dba CLAIRSON PLASTICS), Ocala, FL 2011 – 2014 Medical Device Company serving Major USA Medical Contractors Certified ISO 13485 Lead Auditor; Certified LSS Greenbelt; ISO Representative; FDA Representative Quality Assurance Manager Accountable for monitoring medical device regulations. Demonstrated expertise in Quality Systems ISO 9001 & 13485; certified ISO 13485 Lead Auditor with more than 23 years of implementing ISO 9000 Quality Systems. Scheduled and oversaw annual management meetings. Supplied all analysis pertaining tothe company’s performance including internal/external discrepancies, calculating actual PPM to goals, and Pareto analysis of discrepancies, causes, dispositions, CAPA’s, on-time deliveries, customer satisfaction surveys, continuous process improvement activities, and reports of previous action items. Served as the Lean Manufacturing advisor; responsible for the company’s FDA compliance. Led SPC, FMEA, APQP, CAPAs, Metrology, Cleanroom monitoring and product process control plans. Directed the implementation/maintenance of all controlled documents. Selected Contributions:  Managed all functions of the Quality Control and Quality Assurance activities including inspection, calibration, MRB, customer complaints, statistical process control applications, and validations (IQ, OQ, PQ, PV).  Oversaw company training records and assisted with training development. Trained all employees in QMS; conducted new employee orientations.  Collaborated with Manufacturing to create product specifications that defined processes and inspection requirements for each product.  Participated in the quotes process; evaluated capabilities and FDA requirements.  Reviewed and approved all supplier quality agreements.  As a Certified ISO 13485 Lead Auditor, implemented, trained, and oversaw all internal auditors and internal audit activities; including Internal Auditor training. Represented the company to customers and to the Registrar.  Reduced third party ISO audit findings from six in 2011 (2 majors 4 minors) to zero in 2013. MACLEAN’S EXQUISITE DESIGNS, LLC, Ocala, FL 2010 – Present Design, Patent and Market uniqueproducts Company Owner NATIONAL FRUIT PRODUCT COMPANY, Lincolnton, NC 2004 – 2010 Production/Maintenance Manager Completed additional duties as the Acting Plant Manager. Completed project team planning to install a 750 BPM PET bottling line. Partnered with Pepsi and their suppliers to meet production and quality demands. Developed preventative/predictive maintenance programs; oversaw all plant requisitioning and capital expenditures. Implemented multiple improvement programs including Lean Manufacturing, a work order program that identified areas of concern and immediately assigned resolution/corrective action. Oversaw HACCP, GMP, Calibration, and all plant operations. Selected Contributions:  Instrumental in helping the company became the national Gatorade co-packer, with the lowest number of customer complaints.  Discovered, through data analysis and testing, that the supplied PET bottle was out of specifications, causing a high reject rate for cocked caps. Instrumental in correcting the issue.  Personally developed database to monitor all on-going projects and production scheduling.  Achieved a 13% increase inmonthly revenue over 18 months.  Achieved the highest QSA (Pepsi qualityaudit) score andthe highest AIB (AmericanInstitute of Baking) score in this plant’s history.  Reduced PM and CIP activities from 8 hours to 4 hours; a 50% reduction. Additional experience as a Business Owner of RyDan Precision, Inc. (manufacturing); Director of Operations with Lakeside Precision (manufacturing); President of MacLean Technologies (Quality Management) ; and Inspection/Calibration Supervisor with Moog Contr ols. EDUCATION AND TRAINING Quality Engineering and Statistics, Canisius College, Buffalo, New York, Certified ISO 13485 Lead Auditor, ORIEL STAT A MATRIX Certificate in Certified LSS Greenbelt; Microbiology, Purdue University Certified Mechanical Inspector; Certified Quality Technician, American Society of Quality Control AS9100 Quality Management Systems, Requirements for Aviation, Space and Defense Organizations AS6081 Fraudulent/counterfeit Parts, Avoidance, Detection, Mitigation, and Disposition Metrology, Gage design, R&R studies, CMM programing, GD&T Validations, OPQ, IPQ, PPQ, PV, APQP