Sanaz Mirkhani
- Role
- Avive Solutions Inc.
- Location
- Menlo Park, CA, US
- LinkedIn followers
- 500 followers
About Sanaz Mirkhani
Expert in compliance to FDA 21 CFR 820, 21 CFR Part 4, ISO 13485, and ISO 14971. Over 15…
Experience
Present
Education
San José State University
MS, Industrial Engineering
2002 — 2005
Amirkabir University of Technology - Tehran Polytechnic
Bachelor of Science (BS), Textile Sciences and Engineering
1998 — 2001
Skills
- Fda
- Catheters
- Lean Manufacturing
- Verification and Validation (V&V)
- Failure Mode and Effects Analysis (Fmea)
- Design Control
- Medical Devices
- Capa
- Quality System Compliance
- Ce Marking
- Iso 13485
- U.s. Food and Drug Administration (Fda)
- Fmea
- Design of Experiments
- Quality Control
- Quality System
- V&V
- Quality Engineering
- Corrective and Preventive Action (Capa)
- Supplier Quality
- Iso 14971
- Validation
- Spc
- Minitab
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