Senior Director, Quality Engineering

Job description

The Senior Director, Quality Engineering Combination Products, provides strategic, technical, and quality leadership for all drug–device and biologic–device combination products across the global portfolio. This role owns the quality system elements required under 21 CFR Part 4, ensuring compliant integration of drug GMP (210/211) and device QSR (820/MDR) throughout development, manufacturing, and post-market lifecycle. The Senior Director acts as the Quality Engineering top authority in design controls, risk management, device quality, supplier oversight, and post-market device surveillance. Education: Experience: - Leads and evolves the global Combination Product Quality System, including standards, policies, and processes. Ensures compliance with FDA, EMA, EU MDR, ISO 13485, ISO 14971, and applicable global regulations. Drives quality governance, risk escalation, and cross-functional alignment. - Oversees design controls (820.30) for all device constituents, including DHF, design reviews, V&V, design transfer, and usability/human factors. Influences device architecture, system engineering, and risk-based decision making. - Leads global ISO 14971–compliant risk management for com...