Senior Quality Systems Specialist- CAPA

Medtronic • Tempe, AZ

1d • Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. Onsite- 100% At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Senior Quality Systems Specialist, supporting the Tempe Campus, you will have responsibility for leading the coordination of FDA inspections and ISO 13485 audits, serving as the primary liaison between auditors and site leadership, and driving robust audit preparedness. You will also play a key role in strengthening Quality Management System (QMS) governance by interpreting regulatory requirements, harmonizing site procedures, and ensuring consistent, compliant operations across the organization. Senior Quality Systems Specialist- CAPA Location: Tempe, AZ A Day in the Life: As a Quality Systems leader, you will play a key role in driving site compliance, continuous improvement, and cross-functional leadership. Your day is dynamic and impactful, encompassing: Responsibilities may include the following and other duties may be assigned.

Requirements

• Bachelor’s Degree and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice To Haves

• Preferably 5+ years of 21 CFR Part 820 and ISO 13485 experience
• Lean Six Sigma Certification
• Lead Auditor Certification
• Familiarity with Medical Device Single Audit Program (MDSAP)
• Experience with TrackWise (Sparta)
• Experience with Project Life Cycle Management (PLM) systems such as Agile or Windchill

Responsibilities

• Oversee the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with company policies and regulatory standards.
• Provide expertise and guidance in interpreting internal and external regulations to ensure ongoing compliance.
• Collaborate with operating entities to enforce requirements and ensure regulatory adherence.
• Lead audit and inspection preparation, manage resolution of findings, and liaise with auditing groups and inspectors throughout all audit stages.
• Prepare reports and required documentation (e.g., Corrective and Preventative Actions) for internal and external stakeholders.
• Coordinate legal requests in support of government investigations or litigation.
• Ensure quality assurance programs and policies are regularly maintained and updated.
• Promote the implementation of uniform standards worldwide and facilitate best practice sharing to support the company’s global mission.
• Provide advanced interpretation of FDA 21 CFR 820 and ISO 13485 requirements to ensure robust site-level compliance.
• Strengthen QMS governance by harmonizing procedures across the site, Operating Units, and the enterprise.
• Lead end-to-end coordination of FDA inspections and ISO 13485 audits, managing all aspects of front room, back room, and strategy room operations.
• Serve as the primary liaison between auditors/inspectors and site leadership, ensuring consistent messaging, risk-based response strategies, and controlled documentation flow.
• Drive inspection preparedness through pre-audit risk assessments, gap analyses, and mock audits.
• Translate audit findings into actionable systemic improvements and governance enhancements.
• Lead and support quality systems improvement initiatives.
• Partner with stakeholders to modernize procedures, enhance documentation architecture, and reduce systemic compliance risk.
• Conduct structured risk assessments on audit trends, inspectional observations, and systemic vulnerabilities.
• Facilitate post-audit knowledge sharing and integrate audit intelligence into proactive quality improvement initiatives.
• Apply structured methodologies (DMAIC, Lean Six Sigma, Cause Mapping, and other root cause analysis tools) to address complex quality system issues.
• Lead cross-functional teams to resolve challenging compliance issues and drive measurable process improvements.
• Lead small- to medium-scale projects with competing priorities and tight timelines.
• Influence senior stakeholders and cross-functional partners to achieve aligned compliance outcomes.
• Provide mentorship and technical guidance to quality professionals and project contributors.

Benefits

• 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. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level