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FDA resumes in Laguna Hills, CA

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Test Engineer Software Development

Laguna Niguel, CA
... Working experience with 21 CFR Part 11 and other FDA’s compliance regulations (ISO 13485:2003) Interacted dynamically with Marketing, Business and Project Management teams in clarifying and revising system usability and requirements. Performed ... - 2023 Sep 04

Customer Service General Manager

Santa Ana, CA
... • Directed safety operations and maintained clean work environment to adhere to C FDA and OSHA requirements. • Complied with company policies and government regulations to prevent and detect rule violations and protect organization from fines and ... - 2023 Aug 31

Statistical Analysis Project Manager

Irvine, CA
... Interacted with FDA reviewers for statistical analysis, to explain the quantitative results of clinical studies and approach. Generated results, tables and graphics and worked with medical writer for publication. Mar 2003 to Dec 2003 Statistical ... - 2023 Aug 31

Quality Assurance Data Entry

Placentia, CA
... I performed standardized tests of food, beverages, additives and preservatives to ensure compliance with the regulations on factors such as color, texture and nutrients according to the protocol of the USDA/FDA Department. I did tests to help ensure ... - 2023 Aug 24

Mechanical Engineer Product Design

Huntington Beach, CA
... Founded and developed FDA approved biomedical device I Mar 2015 – Jun 2019 • Inventor of 2 US patents, progressive biomedical healing technology. • Spearhead the synthesis of product design and beneficial technology components. • Review and oversee ... - 2023 Aug 23

Quality Control Drug Safety

Orange County, CA
... Address FDA question for IND in a team environment as a member. Lead and support Principle Investigators in IND application and budget for GMP and Pre IND Engineering run and GMP runs. Demonstratred expertise in method development in new testing ... - 2023 Aug 06

Quality Assurance Customer Service

Lake Elsinore, CA, 92530
... Mix acid with DI water base chemicals to filtrate bone to bone base paste to be diluted to even smaller base bone paste using FDA approved procedures wearing class 7 PPE. Following JITs, MPIs, ISOs & SOPs manuals and using all types of sanitized ... - 2023 Aug 03

General Manager Product Development

San Clemente, CA
... ● Adaptable ● Self-motivated ● Tone Setter Patent Holder ● Medical/Aerospace/Military ● Entrepreneurial/Start-ups ● ISO/FDA/ITAR Budget Development/Management ● Project/Product Management ● Broad Industry Experience Experience Feb 2016 Current ... - 2023 Jul 14

Development Engineer Manufacturing

Irvine, CA
... Acquired extensive experience with FDA design control requirements, FMEA, risk analysis, finite element analysis, 3-D modeling and design, MiniTab, and fluid dynamics. Engaged and updated on materials and process flow for manufacturing - subject ... - 2023 Jun 26

Qa Specialist Team Member

Anaheim, CA
... Successfully capable to handle FDA issued 483 corrective action report timely manner. Able to create time to time SOP if requested by any regulatory agency like NSF, UL or food safety auditor to meet their requirement for GMP certification processes ... - 2023 Apr 13
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