Senior Quality Systems Lead – CAPA & Audit Readiness

Socket.dev; California (MO); On-site; USD 150,000 - 224,000; Full time

Benefits offered by this job

Health insurance

HSA (Health Savings Account)

Life insurance

401(k) with employer match

Paid time off

Tuition assistance

Job summary

Medtronic Neurovascular in Irvine, CA is seeking a Senior Quality Systems Manager to lead CAPA governance and QMS improvements onsite. The role drives audit readiness, ensures compliance with global regulatory requirements, and partners with cross-functional teams to strengthen quality programs and product safety.

Responsibilities include leading CAPA, overseeing QMS processes, coordinating audits, and guiding continuous improvement initiatives to support regulatory inspections and company

Qualifications

• Bachelor's degree and 7+ years of quality or quality systems experience, with 5+ years in leadership.
• Advanced degree with 5+ years leadership experience.
• Experience leading CAPA governance processes, including review boards, metrics, risk-based prioritization, escalation management, and CAPA closure oversight.
• Experience leading or supporting audits and regulatory inspections, including preparation, execution, inspector interaction, and response to findings.
• Experience working within a regulated industry environment and applying QMS requirements to maintain compliance.
• Experience interpreting and implementing regulatory, governmental, and quality system requirements within business processes.

Responsibilities

• Lead the CAPA program, including CAPA review board activities, risk escalation, performance monitoring, prioritization, and oversight of timely and effective CAPA execution and closure.
• Provide leadership, coaching, and direction to the CAPA team to ensure successful execution of quality initiatives, compliance objectives, and business priorities.
• Oversee ongoing Quality Management System (QMS) processes and continuous improvement activities to maintain compliance and drive operational effectiveness.
• Direct audit and inspection readiness activities and coordinate responses to internal, external, customer, and regulatory audit observations and findings.
• Develop, maintain, and improve quality programs, systems, processes, and procedures that support compliance with applicable regulations, standards, and company policies.
• Partner with business and functional teams to evaluate process performance, identify compliance risks, and implement sustainable process improvements.
• Monitor quality system metrics and trends, communicate performance results to leadership, and drive actions that improve quality system effectiveness.
• Coordinate quality-related support for legal, regulatory, and government inquiries while promoting best-practice sharing and standardized quality processes across the organization.

Skills

CAPA governance

Audit readiness

QMS processes

Regulatory inspections

Quality improvement

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree

Tools

TrackWise

Job description

Medtronic Neurovascular in Irvine, CA is seeking a Senior Quality Systems Manager to lead CAPA governance and QMS improvements onsite. The role drives audit readiness, ensures compliance with global regulatory requirements, and partners with cross-functional teams to strengthen quality programs and product safety.

Responsibilities include leading CAPA, overseeing QMS processes, coordinating audits, and guiding continuous improvement initiatives to support regulatory inspections and company