Mike Ornelas
- Role
- Senior Director, Quality Systems at Cepheid
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
Experience
Senior Director, Quality Systems
Mar 2022 — Present · Sunnyvale, CA, US
Provides management Global strategic direction and operational coordination of activities to ensure compliance with FDA, ISO, and other applicable global regulatory requirements as well as alignment with company objectives and Quality Standards. Direct Sunnyvale responsibility and Global oversight for Quality System processes including CAPA, Internal Audits, Learning and Development, Document Control, and Product Safety & Environmental Compliance.
Skills
- Quality Control
- Sop
- Iso 13485
- Quality System
- Supplier Quality
- Manufacturing
- Product Development
- Quality Assurance
- Fda
- Medical Devices
- Capa
- Gmp
- V&V
- Fda Gmp
- 21 Cfr Part 11
- Biotechnology
- Validation
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