Senior Quality Engineer

BioTalent is hiring a Senior Quality Engineer for a medical device company in San Diego to own and continuously improve their Quality Management System across the full product lifecycle. This is a hands-on, high-ownership role reporting directly to the VP. Responsibilities Coordinate and maintain QMS processes and documentation across the organization Lead the design control program in partnership with R&D, clinical, and operations Represent Quality within the change control system — reviewing and approving changes Lead CAPA activities including root cause analysis, problem definition, and effectiveness checks Support NMR and complaint handling, supplier qualification, and incoming inspection Lead the internal audit program and support external audit and inspection readiness Requirements B.S. in a technical discipline 4-5 years in a quality role within a medical device manufacturing environment 3+ years of quality system auditing experience Strong command of ISO quality systems and harmonized standards for medical devices Nice to have: Software-enabled/connected device experience, FDA inspection support, MDR/CE marking, diabetes clinical space background #J-18808-Ljbffr