Senior Manager, RDQA

Role: Senior Manager, R&D Device Quality, overseeing quality systems and compliance for medical devices and combination products throughout development. Responsibilities: provide guidance on design control, human factors, risk management; participate in product risk assessments; review design documentation for safety and manufacturability; support regulatory compliance including FDA, ISO 13485, and other standards; oversee quality for clinical batch manufacturing; lead quality improvement initiatives and audits; serve as SME during inspections; maintain expertise on emerging standards. Requirements: 10+ years in medical device industry, with 2+ years in project management; BS in Engineering or Science (MS preferred); deep knowledge of development activities; experience with 21 CFR 820, ISO 13485, risk management (ISO 14971), and human factors standards; strong analytical, communication, and influencing skills; familiarity with regulatory interactions and quality tools like FMEA, DOE. High-Value: medical devices, combination products, design control, risk management, compliance with FDA/ISO standards, clinical batch oversight, quality system development, cross-functional collaboration. Work Setup: not specified.