Manager, Design Quality Late-Stage Development

Role: Lead Quality Assurance for New Product Introduction (NPI) of combination products and medical devices, ensuring compliance, timely delivery, and meeting business objectives. Responsibilities: oversee quality activities across product transfers, design control, risk management, and regulatory compliance; guide cross-functional teams on device and drug regulations; support audits, inspections, and contract manufacturing quality; develop and implement quality strategies for global manufacturing sites and suppliers; manage quality agreements and communication with external partners. Requirements: Bachelor's in Engineering, Life Sciences, or related field; 7+ years of experience, with at least 5 in Operations Quality Assurance; strong knowledge of combination products, medical devices, manufacturing, and relevant regulations; experience with root cause analysis, CAPA, risk management, and design control; leadership skills and ability to operate independently in a global environment. HighValue: combination products, medical devices, manufacturing processes, design control, risk management, global supply chain, regulatory audits. WorkSetup: not specified.