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Resumes 51 - 60 of 148 |
San Francisco, CA
... South San Francisco, CA Collected regulatory approval information from FDA on drugs and biologics. Maintained web-based department file management system. Designed a professionally coherent system for the company’s regulatory library of internal ...
- 2020 Apr 03
Mill Valley, CA
... Led multi-year hardware / software integration engagement to deliver FDA validated end-of-line production test systems for pacemaker production at St. Jude Medical. Became sole supplier for production testers across SJM product lines. Developed ...
- 2020 Mar 26
San Francisco, CA
... ● Prepare and maintain documents for FDA reviewers, ISO reviewers, and auditors. ● Review and finalized CofA and product specification sheets. Education Computer Software Engineering – Hack Reactor Bachelor of Science: Pharmaceutical Chemistry, June ...
- 2020 Jan 24
Vallejo, CA
... Hyper-V Virtual-servers for monitoring dashboards - wall-monitors, Solarwinds, Event Log Analyzer Coordinated IT Operations to design, manage and deploy server environments Maintained GxP documentation vault for FDA audits Select Staffing S.B. ...
- 2019 Oct 01
San Francisco, CA
... Manage clinical laboratory testing for Pathology Research, including all sources of laboratory samples, SOPS write-up procedure, supplies, and studies performed in compliance with FDA good laboratory Practice regulation. Research Development - ...
- 2019 Jul 03
San Francisco, CA
... • Assured that the personnel is complied with FDA Quality System Regulation and DAMAS Standards. • Promoted quality achievement throughout the organization by analyzing performance data charts against defined parameters. • Defined administrative ...
- 2019 Mar 20
Novato, CA
... 2010-2012, 2017 CSV / QMS / TW SME 2017: Supported User Acceptance Testing (UAT) of TW interactive Audit module (Stratas) in preparation for FDA inspection; determined test strategy, authored test scripts, and coordinated execution through issue ...
- 2019 Mar 11
Berkeley, CA
... Designed and provided oversight to product complaint process and FDA-reportable cases. Developed or co-developed design concepts and numerous product enhancements resulting in the development and launch of the StarClose SE Vessel Closure Device (VCD ...
- 2018 Dec 13
San Francisco, CA
... Led engineering team to troubleshoot tray and pouch packaging failure and re-engineered packaging procedures for validation and to meet FDA standards. Developed machining & cleaning processes for titanium bone screws and soft tissue anchors. ...
- 2018 Jul 09
San Francisco, CA
... ● Familiar with FDA Regulations: 21CFR Part 820, Corrective and Preventive Action (CAPA), Risk Management, Validations, Design Controls, Root Cause Analysis, Medical Device Regulations, Standards, Recalls, Device Failure Investigations, Medical ...
- 2018 May 27