Medical Device Tester
|Job Location||San Francisco, CA, USA|
|Job Length||Three to Six Month|
|Other Required Skills||Medical Device Testing, 21 CFR Part 820|
|Other Nice to Have Skills|
|Minimum Immigration Status||H1B Visa|
|Job Starting Date||September 21, 2018|
|Wage/Salary||Hourly: Depending On Experience|
The ideal candidate should have
* 8 - 15 years of experience in Medical device product verification, Regulatory compliance, Risk Management and SW Hazard analysis activities for Class I, II and Class III medical devices against FDA QSR 820, ISO 13485, AAMI TIR 45, FDA Validation guidance and IEC 62304 and GAMP-5 Computer System Validation (CSV)
* Experience in EU Medical Device regulations and CE marking process and related SOP creation
* Experience in working with Notified bodies and work experience in handling ISO 13485, EU notified body audits
* Experience in ensuring Design Control compliance and Design History file( DHF) maintenance
* Expertise in Test Management, Design verification Strategy and Planning, test execution, Regression test strategy, Design verification summary report ,defect report documentations and onsite-offshore coordination
* Developed the SOPs for Design Verification, Validation, Design Output activities in line with FDA medical device regulations and IEC 62304
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