Service and Repair (S&R) Engineering Quality Director

Medtronic • Minneapolis, MN

2d • Onsite

About The Position

At Medtronic, we push the boundaries of what’s possible to improve lives. We are seeking a proven Service & Repair (S&R) Engineering Quality Director to lead quality and operational excellence across a multi‑site, cross‑functional Service and Repair organization, with the role based in Plainfield, Indiana; Minneapolis, Minnesota; or Fort Worth, Texas. In this highly visible leadership position, reporting to the VP of Global Quality Excellence | Global Quality, you will set strategy and drive execution for Quality Management System (QMS) processes supporting repair, refurbishment, and service operations, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and global regulatory requirements. You will lead and influence teams across Engineering, Operations, and Quality at multiple locations, champion effective CAPA management, embed Good Manufacturing and Documentation Practices, and partner with senior leaders to strengthen post‑market performance, scalability, and continuous improvement—directly supporting patient safety and Medtronic’s mission.

Requirements

• Bachelor’s degree in Engineering and minimum 10 years of combined relevant experience in Operations and Quality within an ISO13485 / FDA 21 CFR Part 820 manufacturing environment and 7+ years of managerial experience.
• OR Advanced degree and minimum 8 years of combined relevant experience in Operations and Quality within an ISO13485 / FDA 21 CFR Part 820 manufacturing environment and 7+ years of managerial experience.

Nice To Haves

• Prior experience in the medical device industry or another highly regulated industry preferred.
• Experience with CAPA management, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Quality Management System (QMS) leadership.
• Service and Repair or post‑market operations experience within a regulated manufacturing environment.
• Lean / Continuous Improvement experience, including Green Belt or Black Belt certification preferred.
• Demonstrated ability to lead or support Lean transformation initiatives, including 5S.
• Experience applying continuous improvement methodologies in a manufacturing or operations environment.
• Bachelor’s degree in Engineering (Industrial, Biomedical, Mechanical, or Electrical preferred).
• Proven experience leading cross‑functional, multi‑site, or multi‑regional initiatives.
• Track record of driving organizational change resulting in measurable improvements in Safety, Quality, Delivery, and Cost (SQDC) performance.
• 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.

Responsibilities

• Guide, deploy, and execute the Medtronic Performance System (MPS), our “one best way” methodology and tools that support our holistic operational excellence program.
• Lead, form, mentor, develop and coach an engineering team on meeting / exceeding performance expectations.
• Ensure that serviced and repaired medical devices meet regulatory, safety, and quality standards.
• Oversee the quality engineering of post-market support, root cause analysis, corrective actions, audits, and supplier quality for S&R.
• Develop and maintain Quality Management Systems (QMS) for S&R operations compliant to ISO standards and FDA regulations.
• Manage a global team responsible for S&R Quality support.
• Collaborate with commercial and operational teams to align service strategies with business goals and customer satisfaction key performance indicators.

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)

What This Job Offers

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