Michael Chellson is a transformational quality assurance and regulatory affairs professional with 35 years of experience leading medical device and in vitro diagnostics organizations to improve efficiency, compliance and customer satisfaction. He has developed and implemented QMS systems across a myriad of single-use and electromechanical devices for globally distributed multinational organizations and SMEs.
Michael has assisted numerous medical device organizations in successfully executing system, process and product improvements that run the gamut from individual system improvement to the development and implementation of complete future-state, best-practice automated life-cycle management systems.
His regulatory and quality leadership experience encompasses management of multiple sites, including international operations in Asia, Central America, the Middle East and Europe. These experiences have provided Michael with a holistic, cultural and global perspective on organizational quality system integration and compliance.
Michael is an accomplished quality system and compliance auditor, having performed hundreds of quality system and operational quality audits for organizations ranging from single sites to global operations with dozens of sites.
He did his undergraduate work at the University of North Texas and holds a Master of Science in business systems and management from the University of Essex in Colchester, England.
Areas of Expertise:
- Quality Management Systems
- Risk Management
- Medical Device Regulations
- Quality Data Management
- Usability and Human Factors
- Organizational Transformation
- Audits and Inspections
- Supply Chain Quality