Providing strategic and operational leadership, the full-time remote Director of Design Quality will manage Design Quality Engineering teams and ensure compliance with global regulatory requirements across hardware, firmware, software, and AI-enabled products. Key responsibilities Lead and develop Design Quality Engineering teams, overseeing design controls, risk management, and product lifecycle activities Collaborate with cross-functional leaders to establish quality strategies and improve Quality Management System processes Utilize post-market data to identify product risks and implement corrective improvements while representing Design Quality during regulatory inspections Required qualifications Minimum of 15 years of related experience in the medical/science/healthcare field, with a Bachelor's degree At least 5 years of management experience with direct reports Expert-level knowledge of Design Controls, Risk Management, and Cybersecurity Familiarity with mechanical, electrical, and software engineering in complex device development Experience with AI-based devices, SaMD, or wearable medical devices preferred; Master's or advanced degree is a plus
Director of Design Quality in workfromhome at Unknown Company
This position is listed as full time and able to be worked remotely.