Senior Quality System Manager, CAPA (Medical Devices)

Location: Onsite in Irvine, California, United States; travel of less than 20% may be required.

Salary: $149,600–$224,400 annually, plus eligibility for a short-term incentive plan.

Company

hirify.global develops healthcare technologies, including neurovascular products that support treatment of complex vascular conditions and improve patient care.

What you will do

• Lead CAPA governance, including review boards, risk escalation, prioritization, performance monitoring, and timely closure.
• Provide leadership, coaching, and direction to the CAPA team.
• Oversee Quality Management System processes and continuous improvement activities.
• Direct audit and regulatory inspection readiness and coordinate responses to findings.
• Develop and improve quality programs, procedures, and compliance processes.
• Partner with cross-functional teams to identify risks, improve processes, and report quality metrics to leadership.

Requirements

• Bachelor’s degree with 7+ years of relevant experience and 5+ years of people leadership, or an advanced degree with 5+ years of relevant experience and 5+ years of people leadership.
• Experience leading CAPA governance, including risk-based prioritization, escalation management, performance metrics, and closure oversight.
• Experience supporting audits and regulatory inspections, including preparation, inspector interaction, and responses to findings.
• Experience working with Quality Management System requirements in a regulated industry.
• Experience interpreting and implementing regulatory, governmental, and quality system requirements.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for this Senior-level role.

Nice to have

• Medical device, pharmaceutical, biotechnology, or other highly regulated industry experience.
• TrackWise or comparable electronic Quality Management System experience.
• Quality, compliance, or process improvement training development and delivery experience.
• Microsoft Visio, Lean Green Belt, DRM Green Belt, Agile, or cross-functional process improvement experience.

Culture & Benefits

• Purpose-driven work focused on improving patient care and healthcare technology.
• Health, dental, vision, life, and disability insurance options.
• Health Savings Account, Flexible Spending Account, dependent daycare account, and tuition assistance.
• 401(k) with employer contribution and match, paid time off, paid holidays, and employee stock purchase plan.
• Employee assistance, wellness, incentive, and retirement programs.