Joe Sinclair is a seasoned professional in Quality Assurance and Regulatory Affairs with over 20 years of experience, including more than 7 years in the medical device industry. They hold a dual Bachelor of Science degree in Biology and Chemistry from Willamette University and are certified as a Lead Auditor for ISO 13485:2016 and ISO 9001. Currently serving as a Senior Quality Management Systems Specialist at Molecular Testing Labs, Joe leads the development and continuous improvement of quality management systems to ensure compliance with regulatory standards. Their extensive background includes leadership roles in various organizations, driving quality initiatives and maintaining compliance with FDA and ISO requirements.
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