Senior Quality Systems & CAPA Leader

Regulatory Jobs; Irvine (CA); On-site; USD 150,000 - 224,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off

Employee stock purchase plan

Job summary

Medtronic Neuroscience in Irvine, CA is seeking a Senior Quality Systems Manager to lead CAPA governance, audit readiness, and quality program improvements. This onsite role requires coordinating with cross-functional teams to ensure regulatory compliance and robust quality systems.

You will mentor the CAPA team, drive performance metrics, support inspections, and partner with legal, regulatory, and business functions to sustain product quality and patient safety.

Qualifications

• Bachelor's degree (or higher) with 7+ years in quality/quality systems and 5+ years in people leadership
• Experience leading CAPA governance processes, including review boards, metrics, risk-based prioritization, escalation, and closure
• Experience leading or supporting audits and regulatory inspections, including preparation, execution, inspector interaction, and response to findings
• Experience in regulated environments applying QMS requirements to maintain compliance
• Experience interpreting regulatory and quality system requirements within business processes

Responsibilities

• Lead the CAPA program, including CAPA review board activities, risk escalation, performance monitoring, prioritization, and timely CAPA execution and closure
• Provide leadership and coaching to the CAPA team to achieve quality initiatives and compliance objectives
• Oversee ongoing QMS processes and continuous improvement activities to maintain compliance and drive operational effectiveness
• Direct audit and inspection readiness activities and coordinate responses to audit observations and findings
• Develop and improve quality programs, systems, processes, and procedures supporting regulatory compliance and company policies
• Partner with cross-functional teams to evaluate process performance and implement sustainable improvements
• Monitor quality metrics and communicate performance to leadership to drive corrective actions
• Coordinate quality-related support for legal, regulatory, and government inquiries

Skills

CAPA governance

Audit readiness

QMS oversight

Regulatory inspections

Quality systems

Process improvement

Leadership

Education

Bachelor's degree

Advanced degree (optional)

Tools

TrackWise

eQMS platforms

Job description

Medtronic Neuroscience in Irvine, CA is seeking a Senior Quality Systems Manager to lead CAPA governance, audit readiness, and quality program improvements. This onsite role requires coordinating with cross-functional teams to ensure regulatory compliance and robust quality systems.

You will mentor the CAPA team, drive performance metrics, support inspections, and partner with legal, regulatory, and business functions to sustain product quality and patient safety.