Michele Kirkpatrick

Michele Kirkpatrick, CBA, CIS LA, has a diverse work experience spanning over several years. Their most recent role is as a Director of Software Quality at Freenome, where they have been working since 2023. Prior to that, they held positions at Adaptive Biotechnologies Corp., where they served as a Director of Software Engineering Compliance and Principal of Software Regulatory & Quality. Michele also worked at Cardinal Health as an International Regulatory Affairs Manager and Principal Regulatory Affairs Specialist. Before that, Michele was a Managing Director at QS Audit, where they provided quality and regulatory consultancy services for the medical device industry. Michele also has experience as a Senior Quality Assurance Engineer at Adaptive Biotechnologies Corp. and held a similar role at QS Audit. In addition, Michele worked at Caradigm, a GE Healthcare company, as a Principal Quality Assurance Engineer, Postmarket Safety Manager, Lead Auditor ISO 13485, 27001 SOC2, and Technical PM. Michele also had a role as a Technical Project Manager, Quality Assurance & Regulatory Affairs at Microsoft Health Solutions Group contractor with Allyis. Michele's earlier experience includes positions as a Sr. Business Systems Analyst at T-Mobile and Project Manager/Senior Business Analyst at Ascentium.

Michele Kirkpatrick obtained a Biomedical Regulatory Affairs Masters Certificate from the University of Washington in June 2015. Michele is also a Certified Biomedical Auditor from the American Society for Quality. In 2016, they obtained an IBITGQ ISO27001:2013 Lead Auditor (CIS LA 2013) certification from IT Governance Ltd. Additionally, they completed a Certificate of Competency in ISO 13485:2016 Medical Device Management Systems and Lead Auditor Course from the British Standards Institution in 2016. Michele also holds a Bachelor of Science degree in Scientific and Technical Communications from the University of Minnesota and an Associate in Arts, Honors degree from North Hennepin Community College, with studies in computer programming, business, Spanish, and art. Michele has further certifications in ITSM/ITIL 4 Information Technology Service Management from IT Governance, IEC 62304 Software Medical Device Life Cycle from Oriel Stat, ISO 14971:2019 Risk Management from Medical Device HQ, and Scrum Master from the Scrum Alliance.