Edgar Fernandez
Sr. Director of Quality Operations, Sunnyvale and Europe.
- Role
- Sr Director of Global Quality Operations at Intuitive
- Location
- Sunnyvale, CA, US
- LinkedIn followers
- 500 followers
About Edgar Fernandez
I\'m a passionate leader, with global experience in the Life sciences manufacturing…
Experience
Sr Director of Global Quality Operations
Apr 2024 — Present · Mexicali, MX
Responsible for Quality Operations for the manufacturing locations at Sunnyvale, Southaven, Arizona, Germany and Bulgaria. My responsibilities include Incoming quality, final product testing and release for both accessories and systems for all product platforms including the DaVinci, Ion and Single port products. I provide direct oversight of the start up our new Bulgaria manufacturing facility that will become the largest manufacturing facility for Endoscopes.Global responsibility to drive consistency and improvement of the global quality operation processes.
Education
Association for the Advancement of the Medical Instrumentation (AAMI)
Independant Course
2006 — 2006
Tecnológico de Costa Rica
Bachiller
1995 — 2001
John E. Reid and Associates, inc.
Independant Course
2007 — 2007
American Society for Quality (ASQ)
Certified Quality Engineer
2004 — 2004
Bureau Veritas Mexico (BvQI)
Independant Course
2005 — 2005
Technological Institute of Costa Rica
Bachelor degree
1995 — 2001
New Skills Academy
Life Coaching Certification
2020 — 2020
Regulatory Affairs Professionals Society
Annual Conference
2007 — 2007
American Society for Quality (ASQ)
Certified Reliability Engineer
2005 — 2005
Skills
- Design Control
- Validation
- Design of Experiments
- Manufacturing
- Quality Assurance
- Calibration
- Product Transfer
- Ce Marking
- Quality System
- V&V
- Medical Devices
- Verification and Validation (V&V)
- Capa
- Six Sigma
- Quality Auditing
- Internal Audit
- Quality Control
- Gmp
- Root Cause Analysis
- External Audit
- Supplier Quality
- Iso 14971
- Change Control
- 21 Cfr Part 11
- Process Improvement
- Iso Standards
- Fda Gmp
- Lean Manufacturing
- Dmaic
- Regulatory Submissions
- Iso 13485
- Leadership
- Testing
- Manufacturing Operations
- Iso
- Fda
- Regulatory Requirements
- Regulatory Affairs
- Spc
- Quality Management
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