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Resumes 1 - 10 of 660 |
San Jose, CA
... All work experience in ISO 13485: xx and FDA 21CFR820 environments. Involved in ISO 13485: xx and FDA 21CFR820 audits as SME. Experienced with ARENA PLM for Document Review, and NMR creation. Experience in assisting Engineering in completing IQ/OQ ...
- Apr 22
Milpitas, CA
... Sunnyvale CA Document Controller/ CAPA Coordinator – Issue, process and implement NOC (Notice of Change) for FDA regulated Medical Products. Assist originators with assessing levels of changes, the corresponding attachments that apply, and creating ...
- Apr 16
San Leandro, CA
... Guidant Cardiac Pacemakers (now Boston Scientific), Saint Paul, MN 1994-1996 1.5 years Data Engineer ETL data engineering produced FDA Clinical Trial Statistics for Guidant Tachycardia team We built and maintained Clinical Data Extraction system. ...
- Apr 11
Dublin, CA
... San Jose ca….Medical Device Assembler…ISO 13485 Build sub-assemblies in the fluidic department using various hand tools FDA regulated work environment Using prints and computer aided drawings. .. GDP…MPI…SOP 09 / 96---07 / 2008 Silicon Valley Test ...
- Apr 11
Santa Clara, CA
... the Regulatory team with preparation and assembling 510(K) and FDA Response Letters ●Received SAP training to submit POs for upcoming Notifying Bodies (NB) audits and procure the goods and services for the Quality Department Loral Space System, Mt. ...
- Mar 30
Pleasanton, CA, 94566
... ***-**** ad4jpj@r.postjobfree.com Experienced hands-on professional with specialties in high tech,bio-technology and bio-medical devices, knowledgeable in various logistics, export and manufacturing processes of medical devices, FDA,GMP,SOP's & ISO. ...
- Mar 24
Menlo Park, CA
... Designed test benches for functional simulation and completed documents used for FDA clearance submission Hardware Developer September 2015 – February 2016 Xilinx IP configuration & top-level integration 1 • AXI-DMA&-GPIO data transfer • Async. ...
- Mar 22
San Jose, CA
... •Support for resolution of FDA audit comment concerning supporting documentation for transporting of materials. •Write and execute shipping test plan for CDMO product. Baxter Healthcare & Lonza – Hayward, CA 05/08-07/19 Validation Engineering II ...
- Mar 19
Milpitas, CA
... • Experimented and contributed with writing a document on biomedical product requirement specification in accordance with FDA regulations, standards, and the Code of Federal Regulations (CFR). • Evaluated and analyzed information obtained from FDA ...
- Mar 17
Hayward, CA
... Department of Ag) SSOP (Standard Sanitation Operating Procedures) HACCP (Hazardous Analysis Critical Control Points) FDA (Food & Drug Administration) GMP (Good Manufacturing Practices) all safety policies and procedures and any other established ...
- Mar 16