Description
Responsibilities: Maintain the quality system in compliance with ISO 13485 and QSR 820Manage Corrective Action and Preventive Action programs; make sure the CA/PA system is actively being used with results analyzed for effectivenessManage the calibration and preventive maintenance programsPerform internal audits and develop team to perform auditsAssist with regulatory, customer, and registration auditsOversee the complaints management processPerform, and participate in supplier qualification audits. Work with the supply chain organization to ensure supplier performance meets our quality and strategic requirementsOversee the training programEnsure Quality objectives are measured and reviewed to ensure effectivenessPrepare data and coordinate management reviewsPosition Requirements: M.S. degree in an engineering or in a scientific field5 to 8 years of relevant experience working with medical device and/or in-vitro diagnostic.In depth experience with ISO 13485 and QSR 820 for in vitro diagnosticPractical experience with ISO 14971, IEC 62304, and IEC 62366Experience managing CA/PA programExperience building quality system from the ground upExperience working with cross-functional teamsPractical experience with lean principlesWillingness to be hands-on with solid problem solving skills