Director of Design Quality

Job Summary

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