Senior Quality System Manager, CAPA - NV - Irvine, CA (Onsite)

We anticipate the application window for this opening will close on - 3 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life 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. Check us out on LinkedIn: Medtronic Neurovascular The Senior Quality Systems Manager provides leadership and oversight for Quality Management System (QMS) activities with primary responsibility for Corrective and Preventive Action (CAPA) governance, audit readiness, and compliance initiatives. This role leads the CAPA team and partners with cross-functional stakeholders to drive the effectiveness of quality programs, strengthen quality system performance, support regulatory inspections, and ensure compliance with applicable regulatory and internal requirements. Primary 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. Required Qualifications (Must Have) 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. Preferred Qualifications (Nice to Have) 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. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic