Senior Quality System Lead: CAPA & Compliance Excellence

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

Benefits offered by this job

Health, Dental and Vision Insurance

Health Savings Account

401(k) with company match

Paid time off

Employee Stock Purchase Plan

Job summary

Medtronic Neuroscience Division in Irvine, CA seeks a senior quality leader to govern CAPA activities, oversee QMS processes, and coordinate audits and regulatory inspections. The role emphasizes leadership, quality program development, and cross-functional collaboration to ensure patient safety and product quality.

The position requires deep experience in regulated environments, CAPA governance, and strong knowledge of quality systems with a track record of process improvement.

Qualifications

• Bachelor’s degree or higher with 7+ years in quality/compliance.
• Experience leading CAPA governance, including reviews and escalations.
• Experience with audits/regulatory inspections and inspector interactions.
• Applied knowledge of QMS in regulated environments.
• Experience with risk-based thinking and process improvements.

Responsibilities

• Lead CAPA program governance and closure oversight.
• Provide leadership to CAPA team and align with quality objectives.
• Maintain and improve QMS processes for compliance and efficiency.
• Coordinate readiness for audits and respond to findings.
• Develop quality programs and drive continuous improvement.

Skills

CAPA governance

Audits & inspections

QMS compliance

Regulatory interpretation

Process improvement

Education

Bachelor's degree

Advanced degree

Tools

TrackWise

eQMS platforms

Microsoft Visio

Job description

Medtronic Neuroscience Division in Irvine, CA seeks a senior quality leader to govern CAPA activities, oversee QMS processes, and coordinate audits and regulatory inspections. The role emphasizes leadership, quality program development, and cross-functional collaboration to ensure patient safety and product quality.

The position requires deep experience in regulated environments, CAPA governance, and strong knowledge of quality systems with a track record of process improvement.