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FDA resumes in Union City, CA

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Test Engineer Medical Device

San Jose, CA, 95126
... San Jose, CA TEST ENGINEER 8/20/2021 – 11/20/2021 Tested the wireless communication, a class 1 medical device, subject to FDA oversight · Executed Wireless Protocols Allergan, Pleasanton, CA (Contract) TEST ENGINEER 4/15/2019 – 6/20/2019 Tested ... - May 10

Supply Chain Project Manager

Half Moon Bay, CA
... Completed development, gained FDA/EMA approval, and assisted in launching over 8 new products in the last 8 years. Budgetary responsibility peaked at over $1.3 billion US per year Staffing responsibility over multiple facilities peak at over 150 ... - May 08

Product Quality A Team

San Jose, CA
... and Improvement ● Supply Chain Management ● Quality Control ● Interviewing and Prescreening ● GMP ● CSF/Quarterly goals ● FDA Audit ● ERT Member/CRP Certified ● PCB Assembly/Soldering/Mil Spec, ● Voyager ● Jira ● AI ● Managed logistics for offsite ... - May 08

Service Representative Patient

San Jose, CA
... Ensured complaints were filed according to FDA guidelines. Assisted other staff members as needed. 03/1990 - 10/1995 Receptionist/Secretary Sumitomo Metal Industries, Santa Clara, CA Supported the Human Resources Department by answering phones, ... - May 04

Customer Service Quality Inspector

San Jose, CA
... Hands-on experience Agile, GMP (Good Manufacturing Practices), ERP (Enterprise Resource Planning) and SAP (Systems Application & Products) Knowledgeable of the FDA, QSR (Quality System Regulations), ISO 13485 (Quality Management System) and 14001 ... - Apr 25

Service Technician Quality Assurance

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

Document Control Specialist

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

Software Developer Data Engineer

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

Medical Device High School

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

Document Control Specialist

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
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