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Resumes 41 - 50 of 224 |
San Jose, CA
... R&D ENGINEERING TECHNICIAN Design and develop process improvements Design and develop manufacturing process for building heart valve Catheter Perform IQ/OQ/PQ on equipment, and disposition NCR’s/CAPA’s as assigned Trained manufacturer personal on ...
- 2021 Aug 30
Fremont, CA
... Investigates customer complaint, deviations and non-conformities, develops CAPA and performs verification before closing. Writes, reviews, and revises Standard Operating Procedures (SOPs). Review and mange Supplier & Customer Quality agreements. ...
- 2021 Aug 06
San Jose, CA
... & Brazil) • Collaborated with CMO for investigation support, complaint sample testing including batch review, deviations, CAPA etc • Decided reportability under EU MDR requirements and US FDA 21 CFR 820 & 821, IS013485, Health Canada Medical Device ...
- 2021 Jun 03
Santa Clara, CA, 95051
... -CAPA Review Cause, follow-up FDA procedure and correction actions request. -Prepare and maintain DHR’s. -ISO-9001 and 13485 support Internal and External Periodical Audit. Omni-Vision Inc – Santa Clara, CA 1/2006 – 4/2016 Document Control ...
- 2021 May 05
Milpitas, CA
... o Worked on automated molding and racking machine QUALITY ENGINEER METTLER-TOLEDO RAININ, LLC FEB 2018 – MARCH 2019 · Lead CAPA and 8D activities for product and process quality issues, ensuring all facets of CAPA activities are addressed including ...
- 2021 Apr 13
Fremont, CA
... issues & Identified work product that did not conform to requirements Excellent documentation practices, QSR/FDA/ISO 13485/CAPA Maintain Recording & Tracing rejects causes Quality Assurance and Incoming/Final Inspection and disposition Follow ...
- 2021 Mar 19
Oakland, CA
... Proper knowledge of filling and ensuring CAPA. Familiar with drug and medical device development process- cGMP, GLP, IND, NDA,BLA PMA, 510k,AND clinical data and research. VOLUNTEER WORK: SHRI SATYA SAI HOSPITAL, PUTTPARTHY, INDIA Performed 4 years ...
- 2021 Mar 04
San Jose, CA
... in Biomedical Engineering at BMS College of Engineering, India GPA - 3.66/4.0 Aug 2013 – May 2017 CORE COMPETENCIES: Quality: ISO 13485, Six Sigma Green Belt, Root Cause Analysis, Verification and Validation, CAPA, FMEA, IFU, GCP/GMP, Design Control ...
- 2021 Feb 22
Fremont, CA
... SLA Breach Analysis Report based on both Response and Resolution, ensuring to get the CAPA (Corrective & Preventive Action) from the resolver teams on timely basis and validate the same. Preparing and presenting Weekly Deck’s and monthly PMR reports ...
- 2021 Feb 19
Castro Valley, CA
... EXPERIENCE CONFIDENTIAL BIOPHARMACEUTICAL COMPANY March 2020 – Present Quality Systems Implementation Lead and Quality Management Systems (QMS) Business Owner for the management of the electronic QMS (eQMS: Deviation, CAPA, Change Control, ...
- 2021 Feb 06