Edwin Lee Email
Executive Manager QAandRA, PartnerandManaging Member, Project Manager @ Second Source Medical LLC
5 free lookup(s).
Edwin Lee Location
- Fremont, CA, US
Edwin Lee Work
- 2007 -now Executive Manager QAandRA, PartnerandManaging Member, Project Manager @
- 2012 -2015 Director, Quality Assurance @
- 2011 -2012 Sr. Director, RA QA @ Avantis Medical Systems
- 2007 -2011 Director, QA QC @
- 2007 -2007 Sr Director, Quality AssuranceandRegulatory Affairs @ LAAX, INC
- 2005 -2007 Plant Quality Assurance Manager @
- 2004 -2005 Director Quality Systems @
- 2002 -2004 Director Quality AssuranceandRegulatory Compliance @
Edwin Lee Education
- San Jose State University
- University of Miami
Edwin Lee Skills
- Regulatory Compliance
- Product Validation
- Design of Experiments
- Inspection
- Change Control
- Design Control
- Start Ups
- Catheters
- FDA
- Manufacturing Engineering
- Ce Mark
- Risk Management
- Quality Engineering
- Continuous Improvement
- Sales
- 21 CFR Part 11
- Quality Assurance
- GMP
- CAPA
- Validation
- Quality Auditing
- Regulatory Requirements
- Software Documentation
- Clinical Trials
- Product Development
- Medical Devices
- Strategy
- Sterilization
- Sop
- 21 CFR
- Quality Systems
- ISO 13485
- Engineering
- Regulatory Affairs
- Testing
- Quality Management
- ISO 14971
- Biocompatibility
- CE marking
- Quality Control
- R&d
- Root Cause Analysis
- Biomedical Engineering
- Medical Device Directive
- Business Development
- Manufacturing
- Quality System
- Supplier Quality
- Mdd
- ISO
- Regulatory Submissions
- Cross Functional Team Leadership
- DMAIC
- V&V
- FDA GMP
- Minitab
Edwin Lee Summary
- Edwin Lee, based in Fremont, CA, US, is currently a Executive Manager QAandRA, PartnerandManaging Member, Project Manager at Second Source Medical, LLC. Edwin Lee brings experience from previous roles at Nevro, Avantis Medical Systems, CARDIMA, INC and LAAX, INC. Edwin Lee holds a San Jose State University. With a robust skill set that includes Regulatory Compliance, Product Validation, Design of Experiments, Inspection, Change Control and more. Edwin Lee has 1 emails on RocketReach.
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