Director, Quality Systems (MedTech)

TL;DR

Director, Quality Systems (MedTech): Leading the company’s Quality Systems strategy, governance, and operational effectiveness to ensure compliance with global regulatory requirements with an accent on Health Hazard Evaluations (HHE) and nonconformance management. Focus on driving consistency, inspection readiness, and the continuous improvement of the Quality Management System (QMS) across the organization.

Location: Onsite in Irvine, CA, United States

Salary: $170,000 - $210,000

Company

hirify.global is a high-growth medical device organization focused on innovation-driven healthcare solutions.

What you will do

• Lead and oversee Quality Systems activities to ensure compliance with internal procedures, FDA, ISO, and MDSAP standards.
• Provide strategic leadership for core QMS processes, including HHE, nonconformance management, and quality metrics.
• Drive continuous improvement initiatives to enhance the scalability and efficiency of the Quality Management System.
• Support internal, external, and regulatory inspections, ensuring readiness and the implementation of sustainable corrective actions.
• Partner cross-functionally with Regulatory, Engineering, Operations, and Clinical teams to integrate quality systems into product lifecycles.
• Build and mentor a high-performing team of quality professionals, fostering accountability and development.

Requirements

• 10+ years of experience in Quality Assurance or Quality Systems within a regulated medical device or life sciences environment.
• 5+ years of leadership experience managing direct reports or cross-functional quality teams.
• Deep understanding of FDA 21 CFR Part 820, ISO 13485, EU MDR, and MDSAP.
• Proven experience leading HHE and nonconformance processes, as well as CAPA and change control.
• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• Must be able to work onsite in a laboratory environment in Irvine, CA.

Nice to have

• Master’s degree in Engineering, Quality, Regulatory Affairs, or Business.
• Certifications such as Lead Auditor, Certified Quality Auditor (CQA), or RAC.
• Experience with electronic quality systems (eQMS) and validation activities.
• Background in innovation-driven or high-growth medical device organizations.

Culture & Benefits

• Comprehensive health package including Medical, Dental, Vision, and Life/AD&D insurance.
• Financial security through 401(k) and annual performance bonuses up to 20%.
• Generous paid leave including vacation, sick days, and paid maternity leave.
• On-site wellness amenities: Wellness Clinic, Fitness Center, and Café.
• Support for work-life balance via Flexible Spending Accounts and an Employee Assistance Program.