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

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

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.

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.

Salary ranges for U.S (excl. PR) locations (USD):$149,600.00 - $224,400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:

• 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)

The following benefits and additional compensation are available to all regular employees:

• 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)

Regular employees are those who are not temporary, such as interns.

Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

Additional Information for Sales Representatives and Other Patient‑Facing Field Employees

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal e-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the e-Verify program, please click here.