Knowledgeable professional with 20+ years of medical device experience in an FDA regulated industry, providing hands-on experience in quality assurance. Seeking a position to further utilize and expand my skills.
Overview
2027
2027
years of professional experience
Work History
Production Operator II
Integra Technologies
Milpitas, CA
2022 - Current
Operated machinery and equipment to ensure efficient production processes.
Monitored production lines for quality control and compliance with safety standards.
Performed QC inspections and testing for incoming, outgoing, and electrical inspections.
QA Associate
Boston Scientific Corporation
San Jose, CA
01.1997 - 01.2022
Review and approve device records, ensuring compliance with all necessary requirements.
Responsible for completing incoming inspection, outgoing material, RPS, and PSRR documents.
Conduct visual and dimensional inspections of purchased parts and materials, ensuring assemblies are consistent with specifications.
Accurately track and document results throughout the inspection process.
Maintain quality documentation in accordance with SOPs, Wis, and GMP.
Efficiently assist engineers with documentation tasks, as needed.
Timely review sterilization records generated by external vendors and approving the release of sterilized products and reviewing C of C for customers.
Involved in training new hire QCDCs.
Actively participates in department improvement projects.
Assembly Operator
Maxim Integrated Products
Sunnyvale, CA
01.1993 - 01.1997
Perform visual inspections for SOIC, SOP, QFP, and micromax.
Efficiently pack and label QFP, DICE, and metal/gold cans.
Bake, seal, and pack chips: Quad, PLCC, SSOP, SOIC.