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)

Contract: 3-6 months

Start: March
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!