Tracy Mandile

Tracy Mandile, RAC, is an experienced professional in Quality Assurance Management, specializing in FDA regulated medical devices. Tracy's career includes roles such as a Senior Quality Assurance Manager at LeMaitre and Repligen Corporation, where they managed quality metrics and audit preparedness. Prior to these positions, Tracy held various validation engineering roles at companies like Pfizer and EMD Millipore. Currently, Tracy works as a Quality Assurance Consultant at TransMedics, Inc., bringing extensive expertise in the quality life-cycle of medical devices.