Amruta Divekar
- Role
- Principal Engineer, Software Quality Validation Cardiac Surgery and Cardiac Assist at Getinge
- Location
- Wayne, NJ, US
- LinkedIn followers
- 500 followers
About Amruta Divekar
Over 15 years of experience in Life Sciences focusing on enterprise software…
Experience
Principal Engineer, Software Quality Validation Cardiac Surgery and Cardiac Assist
Jul 2021 — Present
Skills
- Gmp
- Quality System
- V&V
- 21 Cfr Part 11
- Trackwise
- Test Protocols
- Rtm
- Verification and Validation (V&V)
- Quality Assurance
- Computer System Validation
- Testing
- Capa
- Validation
- Medical Devices
- U.s. Title 21 Cfr Part 11 Regulation
- Change Control
- Corrective and Preventive Action (Capa)
- Electronic Document Management System
- Document Management
- Fda
- Quality Systems
- Quality Control
- U.s. Food and Drug Administration (Fda)
- Summary Reports
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