Quality Assurance Management -Director - Biotech Resume Search
Quality Assurance Management -Director - Biotech Resume Search
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Quality Assurance Management -Director Resume


Desired Industry: Biotech SpiderID: 25824
Desired Job Location: Toms River, New Jersey Date Posted: 3/30/2009
Type of Position: Full-Time Permanent Availability Date: 4/27/09
Desired Wage: 120K
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, 25-50%
Highest Degree Attained: Bachelors Willing to Relocate: Undecided


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.


Experience:
2/2002-Current 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


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


Skills:
Fully Bilingual - English and Spanish
Microsoft Project, Word, Excel, Power Point
Use of Statistical Tools
Management Trainings
Design Control and Quality System (FMEA, CAPA);Medical Device Standards, FDA Standards, GMP, GTP



Reference:
Available upon request.


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