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
Your Role
* 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.
Key Requirements
✅ 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.
📤 Interested? Send your CV and availability today - first shortlist goes out soon!
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