Quality Assurance Consultant

Quality Assurance Consultant - Medical Device Development (Copenhagen 🇩🇰)

An opportunity to support a leading medical‑device organisation in Copenhagen on a high‑impact Quality Assurance assignment. This role focuses on strengthening documentation, design control, and lifecycle quality support within an ISO 13485-regulated environment.

📍 Location: Copenhagen (Hybrid)

Your Role

You will contribute to key quality and compliance activities across development and lifecycle projects, ensuring processes and documentation meet internal standards and regulatory expectations. Responsibilities include:

• Supporting design control activities across software‑related and instrument‑based development projects.
• Managing and maintaining ISO 13485-aligned QMS documentation.
• Overseeing documentation for assay‑related workflows and point‑of‑care instrumentation.
• Providing quality oversight across development and lifecycle management activities.
• Collaborating with engineering, development, and quality teams to ensure robust and compliant processes.

Key Requirements

✅ Experience as a Quality Assurance Consultant within an ISO 13485 medical‑device environment.
✅ Strong background in design control, software documentation, and/or instrument documentation.
✅ Experience with assay‑related documentation or point‑of‑care technologies is an advantage.
✅ Solid understanding of QMS principles, documentation control, and lifecycle quality processes.
✅ Comfortable working within a hybrid structure.

📤 Interested?
Send your CV and availability! First batch of CV's going out today!