1. FELIX A. NEGRON
6413 Conroy Windermere Rd, Apt. 1402
Orlando, FL 32835
Phone: 407-350-9961
E-mail: fansjr13@gmail.com
QUALIFICATIONS
Accomplished, bilingual, professional quality assurance manager with more than
17 years of experience in quality systems, manufacturing fields, safety, and
customer service. Background includes ISO9001/13485 implementation, policies
documentation, developing training programs, interviewing and evaluating of
personnel among others. Highly skilled in staff supervision, budget control,
contract negotiations, and technical evaluations.
EDUCATION
Rensselaer Polytechnic Institute, Troy, New York
Master of Science in Industrial & Management Engineering, 1996
G.P.A. 3.50 out of 4.00 scales
University of Puerto Rico, San Juan, Puerto Rico
Bachelor Business Administration
Major in Statistics, 1995
PROFESSIONAL EXPERIENCE
Quality Control Manager, NFI
Orlando, FL (05/2014 – Present)
 Develop and manage the Quality Management System and administer
the corrective and preventive action program
 Ensure that process and product audits occur according to plan.
Determine areas for improvement based on audit results and recommend
and implement solutions
 In charge of onboarding process for new hires covering all safety policies
and standard operating procedures.
 Raise the level of awareness throughout the shop on the importance
of quality, continuous improvement, and cost reduction.
 Ensure appropriate data and KPI’s data is gathered, analyzed and
reported.
 Act as Safety Coordinator on the facility, supports all corporate safety
initiatives and make sure the facility is OSHA compliance.
 In charge of two trainers and five process/product auditors.
 Train and implement Lean and Six Sigma tools (Root Cause analysis, 5
Why’s, Cause & Effect, 5S)
 Member of corporate Start-up Operations Team to support new facilities
during start-ups on quality, safety, operations, and policies and procedure

2. Site Quality Assurance Manager, BASF
Sparks, Georgia (03/2013 – 09/2013)
 Implement overall quality control, quality assurance, cross contamination
prevention, and microbial contamination prevention programs at the site.
 Serve as the quality leader within the facility in the development and
implementation of systems and procedures to effect compliance with all
applicable standards.
 Implement and maintain a total quality system that includes management
review, document control, training, customer feedback, internal audits,
process improvement and corrective/preventive action activities in
compliance with ISO9001 and BASF global guidelines.
 Supervises all testing operations for the physical and chemical
assessment of components, in-process materials and finished goods in a
manner that these operations are reliable, accurate, and timely.
 Serve as EHS champion for the facility, administrator of the document
control system, and the non-conformance management program.
 Maintains compliance with all safety and environmental regulations and
procedures.
 Supervised, trained, and evaluated a staff of 8 Laboratory Technicians, 1
Laboratory Supervisor, 1 Site Chemist, and 1 Administrative Assistant in
a 24/7 chemical plant.
Quality & Regulatory Manager PR & North Latam, Philips Medical Systems
San Juan, Puerto Rico (03/2010 – 10/2012)
 Ensure compliance to local and federal regulations, standards and codes
applicable to Philips Medical Systems Puerto Rico.
 Develop and implement policies and procedures on safety and health (fire
safety, life safety, OSHA requirement etc.) for the Philips organization in
Puerto Rico to comply with applicable regulations, standards and codes.
 Direct the activities of customer complaints, event reporting, recall and
field product changes in accordance with applicable regulations and
Philips policies.
 Implement and maintain a total quality system that includes management
review, document control, training, customer feedback, internal audits,
process improvement and corrective/preventive action activities in
compliance with the FDA and ISO13485
 Supports the deployment (and development when necessary) of training
programs to meet the needs for field employees to include areas such as
quality & regulatory requirements, customer complaints and safety and
health.
 Lead and facilitate business process improvement initiatives and projects
where applicable.
 Processes legalization of regulatory documents for foreign product
registrations in North Latam to INVIMA and ANVISA
 Maintains and sets-up Regulatory Affairs files and Products Registration.
 Supplies guidance to Commercial and Order Realization regarding
regulatory issues.
 Lead all Business Excellence (BE) initiatives in the country and make
sure they are aligning with region initiatives.

3. Quality Assurance Manager, Model Offset Printing
Humacao, Puerto Rico (2005 – 12/2009) & (11/1997-12/1999)
 Established ISO9001 quality system in one year and under budgeted
 Successfully passed customer audits like Medtronic, Warner Chilcott,
Novartis, Lutron, and Hewlett Packard
 Created, implemented, and maintained all policies and procedures in
compliance with ISO9001, cGMP’s, and OSHA standards
 Safety Officer in charge of implementing procedures and training
personnel
 Performed quality audits at vendors facilities
 Evaluated the market for new product/process introduction, e.g. mailing
operations and digital printing
 Managed the corrective/preventive action program (CAPA), the safety
program, and the training program
 Work closely with customers in new product introductions and giving them
cost reduction ideas before launch
 Supervised, trained, and evaluated a staff of 12 employees
 Prepared metrics reports for management reviews, e.g. Pareto charts,
Control charts, Cause-and-effect diagrams, Questionnaire analysis.
Quality Assurance Manager, Tiffany & Co.
Pelham, New York (02/2001-03/2005)
 Supervised a staff of 1 Quality Engineer, 1 Supervisor and 13 inspectors
in a diamond jewelry production operation
 Managed the department’s fiscal year’s OTPS and PS budget
 Coordinated with Engineering the Stop & Gate Process-Product
Development
 Prepared metrics reports for upper management, e.g., Pareto charts,
Control charts.
 Reduced quality escapes to 0.2% from 1.0%
 Cross train QA inspectors to work efficiently in manufacturing cells
Senior Technical Associate (Production Supervisor), Merrill Lynch
Production Technologies (MLPT)
Piscataway, New Jersey (1999-2001)
 Responsible for day to day operation in a 24/7 document management
and direct mailing facility
 Supervised a staff of 23 employees and performed their evaluations
 Conducted FTE analysis to improve the process on a monthly basis and
to ensure effective labor utilization
Quality Assurance Manager, Flexible Packaging Group
Bayamón, Puerto Rico (1997)
 Developed and implemented quality standards for all pharmaceutical
packages
 Started documentation of all policies and procedures towards ISO9001
certification
 Approved all production samples and technical drawings
 Created all BOM for all contract packaging products

4.  Implemented procedures in compliance with cGMP and OSHA
 Conducted internal and external audits
 Supervised a staff of 7 employees
ADDITIONAL INFORMATION
 ISO9001 and ISO13485 Certified Lead Auditor
 Knowledge of FDA regulations, cGMP’s, SAP, OSHA standards, JDEdwards,
Lean Manufacturing, Cellular Manufacturing, Statistical Techniques, 5S, and
Problem Solving Techniques
 Awarded in 1996 with an AT&T Summer Scholarship For Minorities
REFERENCES
Available upon request