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FDA resumes in Pleasant Hill, CA

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QA QUALITY SYSTEMS

Castro Valley, CA
... Supported inspection readiness and performed as Librarian for 2 successful inspections (FDA and IMB). Associate, Quality Assurance May 2008 – April 2009 (Formerly: CV Therapeutics, Inc.) Implemented and maintained Document Control metrics. ... - 2021 Feb 06

Lean Six Mechanical Engineer

Walnut Creek, CA
... Highly skilled in creating Test Methods, Test Protocols, and writing technical reports as FDA regulations. Experienced in Continuous Improvements (CI), CAPAs, cGMP, and GDP regulations, statistical process control (SPC), MSA, DOE, IQC and, Lean Six ... - 2020 Dec 10

Engineer Quality

Livermore, CA
... Process Controls, Validation and Project Management professional with extensive experience of regulations cGMP, GxP, FDA, ICH, EU, ISO and 21 CFR 11, 820 related to Pharmaceuticals, Biotechnology, Medical Devices and Computerized Systems. ... - 2020 Nov 13

Mechanical Engineer

Vallejo, CA
... as communications lead with a team of colleagues, faculty, and sponsors to create the electro- mechanical machine that uses FDA-approved components • Utilized sub-assemblies in SolidWorks to stage major processes of root-grating automation • ... - 2020 Sep 10

Biomedical Engineering

Hayward, CA
... • The chosen device for this mock document was the Neuroform Atlas Stent System as approved by the FDA. Device Design Project, San Jose State University August 2016 – December 2016 • Created a hand-drawn blueprint and written documentation of a ... - 2020 Aug 30

Executive Chef

Oakland, CA
... meet menu specifications Executive Sous Chef March-2011 to August 2012 Gate Gourmet, San Francisco, California Meeting FDA and HACCP requirements Responsible for monthly presentations and menu executions Maintaining food cost and labor for all ... - 2020 Aug 13

Quality Engineer Manager

Hayward, CA
... Fully accountable for surveillance on ISO-13485 [21 CFR 820] and FDA audits requirements. Management of IATF-16949:2016 and ISO 9001:2015 transitions. TQM implementation and Cellular Manufacturing System. Strategic participation to fully comply with ... - 2020 Aug 09

Senior QA Analyst

San Ramon, CA
... GE HealthCare (Chicago): Quality System Engineer May 2009- May 2010 Responsibilities: Test Imaging solutions for medical devices in a FDA regulated environment, PACS (Picture Archiving and Communications System) providing radiology department with ... - 2020 Aug 07

Mechanical Engineer

Concord, CA
... cleaning plants • Designed, via Solidworks, an innovative piston and mesh self-cleaning filter based on chemical resistance, FDA compliance, dimensional limits • Manufactured and tested filter prototype to ensure efficiency and effectiveness via in ... - 2020 Jul 27

Technician Lab

Hayward, CA
... Worked in a GMP, GLP, GDP, GCP, ISO, Batch Records, OSHA, EH & S, FDA regulated environment. Gilead Science Inc - Fremont, CA LAB TECHNICIAN - Temporary Assignment - Completed 10/2012 - 11/2012 Autoclave equipment to sterilize glassware such as ... - 2020 Jul 09
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