Paul Andreassi Email & Phone Number

-Reporting to the CEO, responsible for all aspects of Quality Assurance and Regulatory Affairs

Responsible for Complaint Handling, Medical Device Reporting, Medical Device Vigilance, and product performance monitoring for all Olympus medical products world wide.

-Reporting to the CEO, I am responsible for all aspects of Quality such as; Design, Manufacturing, Quality Management Systems, Quality Engineering, Risk Management, Compliance, and Post Market Surveillance-Establish and execute global Quality strategy-Lead sustainable Quality organization and compliance transformation-Build high performing service oriented.

Head of Post Market Surveillance for ~$2B USD Monitoring & Analytics Business Group:- Lead Post Market Surveillance organizational transformation consisting of ~250 team members globally- Successfully lead FDA Consent Decree Post Market Surveillance corrective actions resulting in zero FDA 483's within 18 months- Recommended for CEO Award- Responsible for.

Interim VP Quality and FDA Consent Decree supporting roles at:- Philips Healthcare (July 2017 - April 2019)- NSF International (May 2017 - June 2019)- Medtronic (December 2016 - April 2017)- CR Bard (December 2015 - November 2016), Interim VP Quality- Maquet Getinge Group (August 2015 - November 2015)

Auckland, New Zealand

- Reporting to the CEO, responsible for all aspects of global Quality and Regulatory such as; Design, Manufacturing, Quality Management Systems, Quality Engineering, Distribution, Compliance, Post Market Surveillance and Premarket approval- Annual revenue of ~$700m USD and ~3000 employees- Lead sustainable Quality and Regulatory organizational.

Auckland, New Zealand

- Warning Letter Remediation leadership support

- Responsible for Corrections and Removals Process across all BSC sites- Responsible for ensuring timely and compliant Corrections and Removals across all BSC sites

- Global FDA Corporate Warning Letter Workstream Leader for CAPA and Corrections & Removals- Lead development and deployment of standardized global CAPA and Corrections & Removals processes for all BSC sites

- Responsible for leading Quality System improvements across BSC sites globally

- Responsible for Quality Engineering Manufacturing support in Beverly and Danvers MA locations- Quality Lead for outsourcing of manufacturing from MA to Tijuana

- Respsonsible for global S/W service application used by all Field Service Engineers

- Global internal audit process owner- Conduct internal audits globally- Represent Corporate internal audit function during audit- Serve as interim audit manager

- Lead Six Sigma projects in manufacturing, logistics, service, and finance environments

- Interim Director of Quality for a client, resulting in successful Warning Letter Remediation- Provide client support such as; audits, validation, QMS development, complaint handling, etc.

- Responsible for complaint handling, issue escalation, and support of quality improvement initiatives

Master'S Degree, Engineering Management

Bachelor Of Science - Bs, Mechanical Engineering Technology