Service and Repair Engineering Quality Director

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.

• Availability to travel up to 30%.
• Bachelor’s degree in Engineering and minimum 10 years of combined relevant experience in Operations and Quality within an ISO
  13485 / 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 ISO
  13485 / FDA 21 CFR Part 820 manufacturing environment and 7 + years of managerial experience.
• 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.
• 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.