Quality Assurance Consultant

Quality Assurance Consultant - Medical Device Manufacturing (Thuringia 🇩🇪)

Join a leading innovator in medical technology on a critical quality project in Thuringia! We’re seeking an experienced Quality Assurance Consultant to drive compliance, product integrity, and adherence to international standards across the device lifecycle.

Location: Thuringia (Hybrid)
Duration: 12-month contract
Start: ASAP

• Ensure quality and compliance activities in line with ISO 13485
  , EU MDR
  , and global regulatory frameworks.
• Support audit readiness
  , technical documentation, and risk-based quality processes.
• Collaborate with cross-functional teams to maintain GMP standards and robust QMS practices.
• Act as a key advisor for internal quality reviews and regulatory interactions.

• ✅ Proven experience in quality assurance within medical device manufacturing.
• ✅ Strong knowledge of ISO 13485
  , EU MDR
  , and familiarity with FDA 21 CFR Part 820
  .
• ✅ Understanding of precision optical systems
  , diagnostic imaging technologies, and associated sterile handling requirements.
• ✅ Skilled in compliance oversight
  , risk management
  , and technical documentation
  .
• ✅ Detail-oriented, proactive, and collaborative mindset.

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Interested? Send your CV and availability today - first shortlist goes out soon!