Quality Systems Leader – CAPA & Compliance

COV Covidien LP; California (MO); On-site; USD 150,000 - 224,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) Plan with employer match

Paid Time Off

Job summary

Medtronic Neuroscience in Irvine, California, is seeking a quality leader to drive CAPA governance, QMS management, and regulatory readiness in a highly regulated medical device environment. This onsite role requires collaboration across functions and travel less than 20% for audits and inspections.

The position emphasizes leading quality initiatives, monitoring metrics, and ensuring patient safety and compliance while supporting business continuity and process improvement across the

Qualifications

• Bachelor's degree plus 7+ years in quality/compliance/quality systems with 5+ years of people leadership, or an advanced degree with 5+ years of relevant experience.
• Experience leading CAPA governance processes including review boards, metrics, risk prioritization, escalation, and closure.
• Experience leading or supporting audits and regulatory inspections, including prep, execution, inspector interaction, and response to findings.
• Experience in regulated industries and applying QMS requirements to ensure compliance.
• Experience interpreting regulatory and quality system requirements within business processes.

Responsibilities

• Lead the CAPA program and CAPA review board activities, with risk escalation and timely closure.
• Provide leadership and coaching to the CAPA team to achieve quality objectives and business priorities.
• Oversee QMS processes and continuous improvement for compliance and operational effectiveness.
• Direct audit readiness activities and coordinate responses to audit observations.
• Develop and improve quality programs, systems, and procedures to meet regulatory standards.
• Partner with teams to evaluate process performance, identify risks, and implement improvements.
• Monitor quality metrics and report performance to leadership with action plans.
• Coordinate quality support for legal/regulatory inquiries and promote standardized quality processes.

Skills

CAPA governance

Audit readiness

Regulatory compliance

Quality Management System

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree

Tools

TrackWise

Job description

Medtronic Neuroscience in Irvine, California, is seeking a quality leader to drive CAPA governance, QMS management, and regulatory readiness in a highly regulated medical device environment. This onsite role requires collaboration across functions and travel less than 20% for audits and inspections.

The position emphasizes leading quality initiatives, monitoring metrics, and ensuring patient safety and compliance while supporting business continuity and process improvement across the