Senior Director, Quality (Medtech)

TL;DR

Senior Director, Quality (Medtech): Providing strategic leadership to shape and advance global quality roadmaps, ensuring regulatory compliance and patient safety in a medical device environment. Focus on building and leading a high-performing quality organization, strengthening compliance maturity, and navigating complex international regulatory landscapes like FDA and EU MDR.

Location: Must be based in or able to work onsite in Irvine, CA, United States

Compensation: $208,000–$260,000 + 25% annual bonus

Company

hirify.global is a global leader in healthcare technology, driving innovation in patient monitoring and medical devices.

What you will do

• Define and execute a global quality strategy aligned with enterprise growth and regulatory expectations.
• Lead and mentor a high-performing quality organization to support enterprise complexity.
• Collaborate with R&D, Clinical, and Operations to integrate quality principles into the product lifecycle.
• Establish long-range plans for organizational readiness and quality operations.
• Drive continuous improvement and corrective actions from audits and regulatory inspections.
• Provide strategic advisory to executive leadership on quality and risk-related matters.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
• 10+ years of progressive leadership experience within the medical device industry.
• Deep knowledge of global medical device quality systems, including FDA, ISO 13485, ISO 14971, and EU MDR.
• English proficiency: Ability to read, write, and communicate effectively in a professional environment.
• Demonstrated ability to influence senior leaders across global, cross-functional organizations.
• Ability to work onsite in Irvine, CA.

Nice to have

• Master’s degree in Engineering, Life Sciences, or Business.
• Quality or regulatory certifications such as RAC or CQA.
• Experience with software-enabled medical technologies or SaMD.
• Direct engagement experience with regulatory agencies and notified bodies.

Culture & Benefits

• Comprehensive benefits including medical, dental, vision, and disability insurance.
• 401(k) retirement plan and Paid Maternity Leave.
• Access to on-site Wellness Clinic, Fitness Center, and Cafe.
• Flexible Spending Accounts and Employee Assistance Program.
• Supportive environment focused on innovation, patient safety, and professional development.