Quality Systems Specialist

About the role

Medtronic is seeking a driven Quality Systems Specialist to join its IT Quality, Compliance and Risk organization. The role focuses on continuous improvement of quality management systems, ensuring compliance with internal and external standards across the company’s global operations.

Key responsibilities

• Oversee development and maintenance of quality programs, systems, processes and procedures.
• Interpret policies, regulatory and governmental regulations to assure compliance.
• Collaborate with operating entities to conduct process analyses 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 litigations.
• Maintain and regularly update quality assurance programs and policies.
• Facilitate uniform standards worldwide and promote 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 experience.
• Familiarity with ISO 13485, FDA 21 CFR Part 11 and EU Annex 11.

Required skills

• CAPA methodology.
• Root‑cause analysis.
• Project management.
• ISO 13485.
• FDA 21 CFR Part 11.
• EU Annex 11.
• Lean Six Sigma (green/black belt) – nice to have.
• DMAIC – nice to have.

What we offer

• Competitive benefits package.