Global Device Quality Director - Medical Devices

A New Beginning-Genesis 2; United States; On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Dental insurance

401(k)

Paid maternity leave

Tuition assistance

Job summary

A leading global medical device company is seeking a Director of Global Device Quality. This role requires extensive experience in device and combination product quality oversight and regulatory compliance. The ideal candidate has at least 10 years in medical device quality or design assurance and robust skills in risk management and design controls. The position includes leadership responsibilities across device development activities and requires effective collaboration with cross-functional teams to ensure high-quality standards and regulatory adherence.

Qualifications

• Minimum 10 years in medical device quality or design assurance.
• 7+ years focused on new product development for combination products.
• Strong facilitation and negotiation skills.

Responsibilities

• Lead device quality oversight across product portfolio.
• Ensure compliance with global regulatory expectations.
• Provide input to regulatory submissions.

Skills

Leadership in device quality oversight

Risk management

Regulatory compliance

Design control

Technical writing

Education

BA/BS in Mechanical Engineering

Advanced degree desirable

Job description

A leading global medical device company is seeking a Director of Global Device Quality. This role requires extensive experience in device and combination product quality oversight and regulatory compliance. The ideal candidate has at least 10 years in medical device quality or design assurance and robust skills in risk management and design controls. The position includes leadership responsibilities across device development activities and requires effective collaboration with cross-functional teams to ensure high-quality standards and regulatory adherence.