Associate Director, Quality Medical Device Engineer

Role: Associate Director, Quality Medical Device Engineer, overseeing quality activities for drug-device combination products such as prefilled syringes and autoinjectors, ensuring compliance from development through commercialization. Responsibilities: serve as SME for quality management, lead design control and risk management efforts aligned with FDA, ISO, and EU MDR standards, review DHF and validation documentation, support supplier qualification and quality oversight, and participate in design reviews and risk assessments. Requirements: Bachelor's in Engineering or related field; 10+ years in QA or medical device quality within pharma, biotech, or med device industries; experience with combination products, contract manufacturing, and regulatory inspections. Preferred: advanced degree (MS/MBA), certifications like CQE/CQA, and deep knowledge of GMPs, ISO standards, and global regulatory frameworks. High-Value: focus on injectable combination products, late-stage development or commercial products, GxP compliance, and global regulatory experience. Collaboration: partner with Technical Operations, Device Development, Regulatory Affairs, and external manufacturers. Work Setup: not explicitly specified, but implies a senior role with cross-functional involvement.