Michelle Merwin

Director, Quality

Ms. Merwin has over 30 years of regulated industry experience transforming operations to enhance quality. She has managed global quality teams focused on programmatic quality assurance, continuous improvement, and supplier management.  Her diverse background includes work in the commercial laboratory, food and beverage, and medical device industries.  She has directed initiatives such as the development of ISO 9001, ISO 13485, and AS9100 compliant Quality Management Systems, eQMS/MES/ERP design and implementation; and has developed innovative manufacturing solutions such as novel heat treatments for optimizing mechanical properties of additively manufactured (3d printed) orthopedic implants.  Her primary role at Carmell is to ensure comprehensive quality from research and development through manufacturing, distribution, and end-customer use.  Ms. Merwin earned a BS in Electro-Mechanical Engineering Technology from Pennsylvania State University and an MS in Quality Assurance from California State University with a focus on service quality.  She received a Six Sigma Black Belt (Haemonetics/Aberdale) and has completed ISO 13485:2016 Lead Auditor Training.