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.ResponsibilitiesCoordinate and maintain QMS processes and documentation across the organizationLead the design control program in partnership with R&D, clinical, and operationsRepresent Quality within the change control system — reviewing and approving changesLead CAPA activities including root cause analysis, problem definition, and effectiveness checksSupport NMR and complaint handling, supplier qualification, and incoming inspectionLead the internal audit program and support external audit and inspection readinessRequirementsB.S. in a technical discipline4-5 years in a quality role within a medical device manufacturing environment3+ years of quality system auditing experienceStrong command of ISO quality systems and harmonized standards for medical devicesNice to have: Software-enabled/connected device experience, FDA inspection support, MDR/CE marking, diabetes clinical space background#J-18808-Ljbffr