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Capa resumes in San Leandro, CA

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Supplier Quality Engineer

San Mateo, CA
... Physics & History EXPERIENCE Contract Supplier Quality Engineer at Abbott Vascular Structural Heart Dec 2015 - Present -Drove supplier improvement through CAPA and Supplier Change Notifications -Implemented Infinity QS in the Incoming Quality ... - 2017 Aug 06

Manager Quality

Fremont, CA
... • Detected failure mode/rate and root cause, implemented CAPA, improved the field performance, reduced RMA, and achieved customer’s requirements of product quality and reliability. • Validated design, managed product, drove vendor’s improvement, and ... - 2017 Jul 06

Quality Assurance

South San Francisco, CA
... ●Managed CAPA, Change Controls and Deviations Audentes Therapeutics – San Francisco, CA June 2016– August 2016 Regulatory Publisher Consultant Manage day to day submission activities. Key Achievements: ●Setup and implementation of operational ... - 2017 May 03

Engineer Quality

Pleasanton, CA
... FDA regulations 21 CFR part 820 and ISO 13485, 9001 and 10993, cGMP, Technical Report Writing, Statistical Analysis, FMEA, CAPA, Lean, RCA, Origin Lab software, Characterization techniques NMR and XPS, UV-Vis spectroscopy, AFM, DSC, TGA, Rheometer, ... - 2017 Mar 08

Mechanical Engineer Engineering

Fremont, CA
... Performed FMECA and CAPA as required to comply with FDA, ISO, requirements. Prepared and documented technical design review reports, Meeting Minutes, and conducted technical design reviews and presentations to upper management and peers. Identified ... - 2017 Jan 19

Physician Assistant Medical

Lafayette, CA
... Assistants (CAPA) SKILLS: Computer: Familiar with Windows 8.1, MS Word, MS Power Point EMR (Electronic medical records) certified in Epic, NextGen, Prime Med, Office Ally, E-Clinical, Amazing Charts and Veterans Administration medical records. ... - 2016 Dec 07

Technical Support Manager

San Ramon, CA
... to key stakeholders Provided management reports that addressed discrepancies for Corrective Actions and Prevention Actions (CAPA) Created easy-to-use checklists that improved navigation into new version of Trackwise Systems and saved time in ... - 2016 Nov 02

Management Quality

Fremont, CA
... - Maintain calibration systems across organization - Carryout failure analysis, root cause, corrective and preventive action (CAPA), and engage on continuous process improvements around manufacturing & product performance - Maintain organization’s ... - 2016 Sep 30

Regulatory Affairs, Medical Device, Pharmaceutical, Biotechnology

San Francisco, CA
... Design dossiers and Master Product Files • Solid understanding of 21 CFR, ICH guidelines, QSR (21CFR 820), cGMP, cGLP, GCP, CAPA, eCTD submissions, STED submissions, FMEA, CFGs, MDD 93/42/EEC, IVDD 98/79/EC, MEDDEV, ISO 13485, ISO 14971, quality ... - 2016 Sep 22

Technical Writer

Mountain View, CA
... Once RCA was completed Joe developed Corrective and Preventative Actions (CAPA), and conducted follow-up Effectiveness Checks to ensure CAPAs were working as intended. He has conducted dozens of Gap-Analysis tasks and developed Action Plans in order ... - 2016 Sep 02
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