Ofir Levit Email
QA and RA Manager @ Medasense Biometrics Ltd.
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Ofir Levit Location
- Israel
Ofir Levit Work
- QA and RA Manager @ (January 2025 - Present)
- QA and RA Manager @ (January 2018 - January 2025)
- QA and RA Manager for Medical Devices and Computerized Systems @ (January 2016 - January 2018)
- QA and RA Senior Engineer @ (January 2013 - January 2016)
- QA Validation Engineer @ (January 2011 - January 2013)
Ofir Levit Education
- Tel Aviv University
M.Sc. (Medical Sciences)
2008-2010 - The Hebrew University of Jerusalem
B.Sc. (Plant and Environmental Sciences)
2004-2007 - Tel-Hai University of Kiryat Shmona in the Galilee
Practical Engineer (Biotechnology)
1998-2000
Ofir Levit Skills
- 510(k)
- Auditing
- CRA
- Cell Culture
- Certified Lead Auditor
- Clean Rooms
- Cleaning Validation
- Clinical Research
- Computerized System Validation (CSV)
- FDA 21 CFR Part 820
- FDA QSR
- Gage R&R
- Good Clinical Practice (GCP)
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
- IEC 62304
- ISO 13485
- ISO 14971
- In Vitro Diagnostics (IVD)
- Infrastructure
- MDSAP
- Management
- Manufacturing Process Improvement
- Medical Device Manufacturing
- Medical Device Quality Assurance
- Medical Device Regulation (MDR)
- Medical Devices
- Policies & Procedures
- Process Validation
- Project Oversight
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Regulatory Compliance
- Research Project Management
- Risk Management
- Scanning Electron Microscopy (SEM)
- Strategic Planning
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- Validation
- Verification and Validation (V&V)
Ofir Levit Summary
- Ofir Levit, based in Israel, is currently a QA and RA Manager at Medasense Biometrics Ltd.. Ofir Levit brings experience from previous roles at Accurate Medical Therapeutics, Teva Pharmaceuticals, Exalenz Bioscience Ltd. and Omrix Biosurgery Israel. Ofir Levit holds a 2008 - 2010 M.Sc. in Medical Sciences @ Tel Aviv University. With a robust skill set that includes 510(k), Auditing, CRA, Cell Culture, Certified Lead Auditor and more. Ofir Levit has 1 emails on RocketReach.
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