Paul Andreassi Email & Phone Number
EVP, Chief Quality and Regulatory Officer @ Inogen
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Paul Andreassi Location
- Boston, MA, US
Paul Andreassi Work
- EVP, Chief Quality and Regulatory Officer @ (July 2025 - Present)
- Senior Vice President Quality and Regulaotry @ (April 2024 - July 2025)
- Vice President of Quality @ (October 2023 - March 2024)
- Executive Vice President Quality Assurance @ (June 2021 - October 2023)
- Head of Post Market Surveillance @ (April 2019 - June 2021)
- Independent Consultant @ Self-employed (August 2015 - April 2019)
- Vice President Quality Assurance and Regulatory Affairs @ (January 2009 - July 2015)
- Independent Consultant @ (October 2007 - January 2009)
- Manager, Corrections and Removals @ (January 2005 - August 2007)
- Worksteam Leader - FDA Corporate Warning Letter @ (January 2005 - August 2007)
- Principal Quality Engineer @ (January 2005 - August 2007)
- Senior Quality Engineer @ (January 2004 - January 2005)
- Program Manager - Customer Services Mobile Solutions @ (March 1999 - October 2003)
- Corporate Internal Auditor @ (March 1999 - October 2003)
- Six Sigma Black Belt @ (March 1999 - October 2003)
- Quality System Specialist @ Medical Devices Consultants Inc. (MDCI) (January 1996 - March 1999)
- Corporate Quality Engineer @ (January 1992 - January 1996)
Paul Andreassi Education
- Tufts University
Master's degree (Engineering Management)
2002 - Northeastern University
Bachelor of Science - BS (Mechanical Engineering Technology)
1995
Paul Andreassi Skills
- 21 CFR
- Auditing
- Business Process Improvement
- Business Transformation
- Change Management
- Coaching
- Complaint Management
- Compliance Remediation
- Continuous Improvement
- Corrective and Preventive Action (CAPA)
- Cross-functional Team Leadership
- Cultural Transformation
- Customer-focused Service
- Executive Leadership
- FDA GMP
- Gemba
- Global Strategy
- ISO 13485
- Internal Audits
- Kaizen
- Leadership
- Management
- Medical Devices
- Operational Excellence
- Organizational Development
- Post Market Surveillance
- Process Validation
- Product Quality
- Quality Assurance
- Quality System
- Recalls
- Regulatory Compliance
- Root Cause Analysis
- Six Sigma Black Belt
- Supplier Quality
- Supplier Quality Management
- Team Building
- Validation
- Verification and Validation (V&V)
Paul Andreassi Summary
- Paul Andreassi, based in Boston, MA, US, is currently a EVP, Chief Quality and Regulatory Officer at Inogen. Paul Andreassi brings experience from previous roles at Inogen, Olympus Corporation, Sirtex Medical Limited and Philips. Paul Andreassi holds a Master's degree in Engineering Management @ Tufts University. With a robust skill set that includes 21 CFR, Auditing, Business Process Improvement, Business Transformation, Change Management and more. Paul Andreassi has 2 emails and 2 mobile phone numbers on RocketReach.
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