Sr Director, Quality (Medtech)

TL;DR

Senior Director, Quality (Medtech): Leading the global quality roadmap to support innovation, regulatory compliance, and market access with an accent on quality systems and enterprise risk mitigation. Focus on driving global compliance strategies, overseeing regulatory inspections, and ensuring patient safety across international operations.

Location: Onsite in Irvine, CA, United States

Salary: $200,000 - $260,000

Company

hirify.global is a global leader in healthcare technology specializing in innovative medical device solutions and strict regulatory compliance.

What you will do

• Define and execute the global quality strategy aligned with enterprise growth and regulatory expectations.
• Assess global quality risks and implement strategies to strengthen compliance and mitigate enterprise risk.
• Monitor global regulatory trends and serve as a strategic advisor to executive leadership on complex compliance matters.
• Ensure strict adherence to FDA Quality System Regulation, ISO 13485, EU MDR, and MDSAP requirements.
• Lead the corporate quality audit strategy and manage regulatory inspections, including those from the FDA.
• Oversee field action processes, ensuring compliant execution of recalls, corrections, and customer notifications.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 10+ years of progressive leadership experience within the medical device industry.
• Deep knowledge of global quality systems and regulatory frameworks (FDA, ISO 13485, EU MDR).
• Demonstrated ability to influence senior leaders across global, cross-functional organizations.
• Ability to work onsite in a laboratory environment in Irvine, CA.
• Proficiency in English for technical documentation and cross-functional communication.

Nice to have

• Master's degree in Engineering, Life Sciences, or Business.
• Professional certifications such as RAC or CQA.
• Experience with software as a medical device (SaMD) or digital health technologies.
• Direct experience engaging with regulatory agencies and notified bodies.

Culture & Benefits

• Comprehensive health coverage including Medical, Dental, Vision, and Disability Insurance.
• Financial security through a 401(k) plan and an annual performance bonus of up to 25%.
• Generous leave policy including Vacation, Sick leave, and Paid Maternity Leave.
• On-site wellness amenities such as a clinic, fitness center, and café.
• Additional perks including Pet Insurance and an Employee Assistance Program.