Engineer Quality

**** ********* ***** **** ***** NEW JERSEY *****

732-***-**** *******@*****.***

MARIA A.MUNOZ

PROFESSIONAL OBJECTIVE

To apply my experience in quality management and quality systems along with my validation

expertise and project management skills for successful business objectives in industry.

EMPLOYMENT

2/2002-3/2009 Musculoskeletal Transplant Foundation (MTF) Edison, NJ

Associate Director Project & Portfolio Management

Led project management team for new tissue introduction through the product

development cycle to product implementation and successful market launch. Project

delivered on schedule.

Managed budget and technical resources for projects

Developed business partner contracts in support of projects

Developed quality system requirements associated with the validation plans for projects

Associate Director Quality Engineering/Laboratory Services

Implementation of validation activities as it relates to the aseptic processing of human

tissue implants and medical devices.

Technical consultant in project teams as it relates to project management of validation

tasks and new allograft launches.

Management of nine quality engineers across three MTF facilities responsible for timely

qualifications of equipment, sterilization and packaging processes and statistical analysis

for process improvements and problem resolution.

Management of the MTF Edison, NJ Analytical Laboratory with five staff members who

supports chemical analytical testing.

Management of the MTF Jessup, Pa. Microbiology Laboratory with ten staff members

responsible for the microbiological testing of water, chemicals, environmental samples and

sterility testing.

9/1995-11/2001 Intel, PR LTD Las Piedras, PR

Senior Process Quality Engineer

Implementation of quality control systems in the manufacture of electronic circuit cards

(Surface Mount Technology - SMT, Post Inspection, End of Line Inspection, and

Outgoing Quality Audit - OQA).

Monitored quality indicators for all desktop, server, server adapter, and NIC lines. Led a

task force to address key quality items: (manual assembly area, secondary side soldering,

Top Ten process) - top drivers in the pareto analysis.

Interfaced with the New Product Introduction (NPI) to support pilots on new products and

ensure successful qualifications and drive for immediate ramp up.

Addressed key quality opportunities through the Quality Action Notice

(QAN) forum.

Supervised an OQA team of 22 inspectors and 1 process auditor.

8/1992-9/1995 Johnson and Johnson CPI Las Piedras, PR

Senior Validation Scientist / Quality Engineer

Implemented and coordinated the Supplier Management Program for the top three raw

material suppliers. Tasks included auditing these suppliers, and validating that their

products met the certification criteria.

Defined and deployed an SPC program with a third party software for fluids, toothbrush

assembly, and floss manufacturing processes.

Performed validation of manufacturing processes such as waxers for dental floss, volume

fillers, and packaging processes for the fluids products division.

Authored and executed validation protocols in the form of statistical analyses, process

improvement directives, and technical reports.

4/1992-8/1992 Productos Electronicos Industriales, Santa Isabel, PR

Senior Quality Engineer

Implemented quality control instructions for various products based on customer

specifications.

Improved inspection techniques to provide feedback for product quality.

QE customer corporate interface on various commercial and military program startups.

This involved monthly data reporting to the customer on product performance,

coordination, and resolution of customer complaints.

12/1983-12/1991 International Business Machines (IBM) Owego, NY

Senior Quality Engineer

Designed and implemented process systems for circuit board assembly such as soldering

technology and wet processes.

Defined quality systems for the integration of shop floor control systems together with

SPC.

Led cross-functional teams in the generation and publication of the IBM workmanship

standards as it applied to military programs.

EDUCATION

1980-1984 New Jersey Institute of Technology Newark, NJ

B.S. Chemical Engineering

Graduated Cum Laude

RELATED TRAININGS/CERTIFICATIONS

Statistical Process Control (QMS) Failure Mode and Effects Analysis (FMEA) ISO 9000 Quality Systems /

Auditing GMP Standards and Compliance Quality Action Notice (QAN) Process Managing Through People

(MTP) Mastering Managerial Skills Successfully Managing People Validation Process (Validation Institute &

Consulting) KEPNOR TREGUE Project Management Portfolio Management

PROFESSIONAL AFFILIATIONS

American Society for Quality Control (ASQC) Six Sigma Forum Pharmaceutical Parenteral Association (PDA)

LANGUAGES

Fully Bilingual - English and Spanish

REFERENCES

Available upon request

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