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!