On-site Full-time

Medtronic is hiring a Quality System Specialist

About the Role

Medtronic is seeking a Quality Systems Specialist to join our team in Rolo, Italy. You will be responsible for ensuring the overall implementation of the Quality Management System and maintaining compliance within our distribution network. At Medtronic, we lead with purpose and engineer solutions to generate real outcomes for patients.

What You'll Do

  • Serve as the first point of contact on quality topics for processes performed in the local distribution center.
  • Support local stakeholders by building quality knowledge, supporting detailed process implementation, and using project management and quality tools for continuous improvement.
  • Manage ISO certification activities for ISO 13485:2016 and provide expertise in interpreting policies and regulations to assure compliance.
  • Use Key Performance Indicators to drive actions and continuous improvement initiatives.
  • Perform internal audits or Gemba Walks to verify process implementation and compliance, working with operational teams to drive improvements.
  • Increase awareness of Quality topics and embed a Quality mindset in the organization to put patients first.

What We're Looking For

  • Bachelor’s degree in engineering, business management, or a similar field.
  • Minimum of 2 years of relevant work experience in a highly regulated environment (e.g., Pharmaceutical, Medical Technology, Automotive, or Logistical operations).
  • Knowledge and experience with ISO standards, specifically ISO 9001 and ISO 13485.
  • Good communication and collaboration skills.
  • Command of the Italian and English languages, both verbal and written.

Nice to Have

  • Master’s degree in Engineering, Business Management, or similar.
  • Experience in the Medical Device or Pharmaceutical industries.

Benefits & Compensation

  • Competitive Salary
  • Flexible Benefits Package
  • Short-term incentive plan (Medtronic Incentive Plan)

Work Mode

This is an onsite position based in Rolo, Italy.

Required Skills
Quality Management SystemsMedical Device RegulationsISO 13485AuditingCAPAProcess ImprovementDocumentationRegulatory ComplianceRisk ManagementMicrosoft Office
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About company
Medtronic

Medtronic is a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. The company leads global healthcare technology, attacking challenging health problems to alleviate pain, restore health, and extend life.

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Job Details
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Posted 3 months ago