Senior Quality Systems Specialist

We anticipate the application window for this opening will close on - 5 Mar 2026

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.

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.

Location:

Tempe, AZ

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.

• 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.

• QMS Governance & Regulatory Expertise: 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.

• Audit & Inspection Leadership: 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.

• Quality Systems Transformation & Harmonization: Lead and support quality systems improvement initiatives. Partner with stakeholders to modernize procedures, enhance documentation architecture, and reduce systemic compliance risk.

• Risk Assessment & Knowledge Management: 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.

• Problem Solving & Continuous Improvement: 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.

• Project Leadership & Mentorship: Lead small- to medium-scale projects with competing priorities and tight timelines. Influence senior stakeholders and…