Shani Yogev Katz
Sr. Quality Assurance Manager at Veracyte
- Role
- Ivd Sr Quality Manager at Veracyte, Inc.
- Location
- Sunnyvale, CA, US
- LinkedIn followers
- 500 followers
About Shani Yogev Katz
Experienced Quality Assurance professional with a demonstrated history of working in the medical device industry. Skilled in Quality Systems, Design Control, ISO 13485, ISO 14971 and 21 CFR 820 Compliance and Regulatory Requirements. Strong quality assurance professional with a B.Sc focused in Biomedical Engineering from Tel-Aviv University.
Experience
Ivd Sr Quality Manager
Aug 2025 — Present
Education
Tel Aviv University
B.Sc, Biomedical Engineering
2005 — 2009
Skills
- Quality Assurance
- Ce Marking
- Biomedical Engineering
- Validation
- Drug Delivery
- Quality System
- V&V
- Regulatory Affairs
- Lifesciences
- Quality Management
- Life Sciences
- Quality Control
- Biomechanics
- Gmp
- Regulatory Requirements
- Medical Imaging
- R&D
- Design Control
- Fda
- Medical Devices
- Capa
- Regulatory Submissions
- 21 Cfr Part 11
- Biomaterials
- Iso 14971
- Design of Experiments
- Manufacturing
- U.s. Food and Drug Administration (Fda)
- Iso 13485
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