Quality Systems Specialist – IT Quality & Compliance

About the role

Medtronic is seeking a motivated Quality Systems Specialist to join its IT Quality, Compliance and Risk organization. The role focuses on ensuring that IT‑related quality management systems meet internal and external standards, supporting the company’s mission to deliver safe and effective medical technologies worldwide.

Key responsibilities

• Oversee development and maintenance of quality programs, systems, processes and procedures.
• Interpret and apply policies, regulatory and governmental regulations to assure compliance.
• Collaborate with operating entities to analyze processes and enforce requirements.
• Lead audit and inspection preparation, manage findings, and liaise with auditors.
• Prepare corrective and preventive action (CAPA) reports and documentation for stakeholders.
• Coordinate legal requests supporting government investigations or litigation.
• Maintain and regularly update quality assurance programs and policies.
• Facilitate global uniform standards and best‑practice sharing.

Required profile

• Bachelor’s degree.
• 2+ years experience supporting IT quality, compliance or validation in regulated industries.
• Experience with CAPA and root‑cause analysis.
• Project management skills.
• Life‑science industry background.

Required skills

• ISO 13485
• FDA 21 CFR Part 11
• EU Annex 11
• CAPA methodology
• Lean Six Sigma (Green/Black Belt) or DMAIC
• Project Management

What we offer

• Opportunity to work for a global leader in medical technology.
• Collaborative environment focused on patient‑first innovation.
• Professional growth within a purpose‑driven organization.