Celldex

Associate Director, Quality Medical Device EngineerThe Associate Director, Quality Medical Device Engineer will lead quality oversight activities for drug-device combination products, including prefilled syringes, autoinjectors, on-body delivery systems, and related medical device constituents. This position will partner closely with Technical Operations, Device Development, Regulatory Affairs, Clinical, Supply Chain, and external manufacturing partners to establish and maintain compliant quality systems and ensure the successful development and commercialization of combination products.ResponsibilitiesServe as the Quality lead and Subject Matter Expert (SME) for combination product and medical device constituent quality activities.Provide strategic oversight of combination product development programs from concept through commercialization.Ensure compliance with FDA 21 CFR Part 4, 21 CFR Part 820/Quality Management System Regulation (QMSR), applicable ISO standards, EU MDR...