Mike Collette Email & Phone Number
Executive Quality and Regulatory Consultant @ Semi-Retired
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Mike Collette Location
- Gardner, MA, US
Mike Collette Work
- 2025 -now Executive Quality and Regulatory Consultant @
- 2025 -2025 Director RA and QA @
- 2023 -2025 Director of Regulatory Affairs and Quality systems @ Reveal Lasers LLC
- 2018 -2023 Director of Quality Compliance and Regulatory Affairs @
- 2017 -2017 Sr Validation Analyst, Enterprise Applications IT @
- 2016 -2017 Executve Consultant @
- 2015 -2016 Vice President of Quality @
- 2015 -2015 Executive Consultant @ Micron Products
- 2013 -2015 Executive Consultant @ Atrium Medical
- 2012 -2013 Vice President, Quality @
- 2010 -2012 Director, Quality Engineering and Regulatory Affairs @
- 2009 -2010 Director, Quality and Regulatory Compliance @
- 2007 -2009 Director, Post Market Surveillance @
- 2006 -2007 Quality Manager @ Vaupell Northeast Molding & Tooling
- 2004 -2006 Director of Quality @
- 2003 -2004 Manager of Complaint Invesitgations @ Abbott Labs - Medisense Products
- 2002 -2003 Director RA and QA @ Photoelectron Corp.
- 2000 -2002 Director QA and RA @
- 1997 -2000 OEM Group Director RA and QA @ TFX Medical
- 1995 -1997 Quality Engineer - Microelectronics Division @
- 1988 -1995 QA Supervisor @ Chem Design
Mike Collette Education
- University of Massachusetts Dartmouth
BS (Chemistry)
1981-1983
Mike Collette Skills
- Medical Devices
- Change Control
- GMP
- ISO 13485
- CAPA
- Quality System
- FDA
- Biotechnology
- Design Control
- Continuous Improvement
- ISO
- Regulatory Affairs
- Quality Management
- SPC
- Sterilization
- Six Sigma
- Validation
- 21 CFR Part 11
- Quality Assurance
- Quality Control
- V&V
- ISO Standards
- Verification and Validation (V&V)
- Corrective and Preventive Action (CAPA)
- Training
- Leadership Development
- Development
- Business Development
- Supply Chain
- Corrective and Preventive Action Capa
- Verification and Validation V&V
- Verification and Validation
- Corrective and Preventive Action
Mike Collette Summary
- Mike Collette, based in Gardner, MA, US, is currently a Executive Quality and Regulatory Consultant at Semi-Retired. Mike Collette brings experience from previous roles at KYRA Medical, Inc., Reveal Lasers LLC, Image Diagnostics, Inc and Cynosure, Inc.. Mike Collette holds a 1981 - 1983 BS in Chemistry @ University of Massachusetts Dartmouth. With a robust skill set that includes Medical Devices, Change Control, GMP, ISO 13485, CAPA and more. Mike Collette has 3 emails and 1 mobile phone numbers on RocketReach.
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