Director, Design Quality

About the role

For our client, we are seeking a Director, Design Quality to join the team of a leader in the Healthcare space. This leader will shape design quality strategy across hardware and software for complex medical products, with a strong emphasis on design controls, risk management, and compliance. The role partners closely with engineering, regulatory, and executive stakeholders to strengthen quality systems and support product lifecycle excellence. It is a highly visible position focused on improving governance, using post-market insights to reduce risk, and building a patient-centered quality culture.

Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Lead and develop Design Quality Engineering teams across hardware and software
• Oversee design controls, risk management, and product lifecycle activities
• Collaborate with cross-functional leaders to define quality strategies and requirements
• Enhance Quality Management System processes and governance for compliance and effectiveness
• Utilize post-market data to identify risks and implement corrective actions
• Represent Design Quality during regulatory inspections and audits
• Foster a patient-focused quality culture and drive organizational change
• Recruit and develop high-performing teams, ensuring succession planning
• Report quality risks and performance metrics to executive leadership

Qualifications

• 15+ years of experience in the medical, science, or healthcare field, or equivalent
• Bachelor’s degree required
• 5+ years in a management role with direct reports
• Expert knowledge of Design Controls, Risk Management, and Cybersecurity
• Familiarity with mechanical, electrical, and software engineering for complex devices
• Experience in Software Development Lifecycle, especially with embedded software and mobile applications
• Strong collaboration skills with cross-disciplinary teams
• Experience with AI-based devices, SaMD, or wearable medical devices preferred

Benefits

• Medical, dental, and vision insurance starting on the first day
• Paid holidays and PTO
• 401K with company match
• Employee Stock Purchase Plan
• Paid parental leave and pet insurance discount
• Cultural Committee and charity events

Pay

$182,000 – $237,000 annually