Senior Quality System Manager, CAPA - NV - Irvine, CA (Onsite)
About The Position
At Medtronic Neuroscience, we are redefining what's possible in neurological and spinal care, bringing together innovation, expertise, and partnership to improve lives around the world. The Neurovascular (NV) Operating Unit develops technologies that support the treatment of complex vascular conditions and advance patient care through quality, compliance, and operational excellence. The Quality function partners across the organization to maintain effective quality management systems, drive compliance with global regulatory requirements, and support continuous improvement initiatives that ensure product quality, patient safety, and business continuity. This position is based in Irvine, California and is an onsite role. Travel of less than 20% may be required to support audits, inspections, business activities, and cross-functional collaboration.
Requirements
- Bachelor's degree and 7+ years of relevant quality, compliance, or quality systems experience with 5+ years of people leadership experience; OR Advanced degree and 5+ years of relevant quality, compliance, or quality systems experience with 5+ years of people leadership experience.
- Experience leading Corrective and Preventive Action (CAPA) governance processes, including review boards, performance 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 Quality Management System (QMS) requirements to maintain compliance.
- Experience interpreting and implementing regulatory, governmental, and quality system requirements within business processes.
Nice To Haves
- Experience within the medical device, pharmaceutical, biotechnology, or other highly regulated industries.
- Experience using TrackWise or comparable electronic Quality Management System (eQMS) platforms.
- Experience developing and delivering quality system, compliance, or process improvement training programs.
- Proficiency with Microsoft Visio for process mapping, workflow design, and documentation.
- Lean Green Belt, Design for Reliability and Manufacturability (DRM) Green Belt, or similar continuous improvement certification.
- Experience applying Agile methodologies and leading cross-functional process improvement initiatives.
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.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
