Quality Assurance Consultant
Quality Assurance Specialist - Medical Device Manufacturing (Poland 🇵🇱)
Join a global innovator in medical technology on a critical manufacturing project in Poland! We're seeking Quality Assurance Specialists to uphold product integrity, compliance, and patient safety across the entire device lifecycle.
📍 Location: Poland (Hybrid)
📅 Duration: 12-month contract
🚀 Start: ASAP
Your Role
- Ensure quality systems and processes comply with ISO 13485, EU MDR, and global regulatory standards.
- Drive audit readiness, CAPA management, and continuous improvement initiatives.
- Collaborate with engineering, manufacturing, and regulatory teams to maintain GMP standards and robust risk management.
- Review and approve technical documentation, validation protocols, and change controls.
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 technologies such as orthopedic implants, powered surgical instruments, and operating room solutions.
✅ Skilled in compliance oversight, risk-based quality systems, and audit preparation.
✅ Detail-oriented, proactive, and collaborative mindset with strong problem-solving skills.
📤 Interested? Send your CV and availability today - first batch of submissions go out this week!
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