Design Quality Engineer

Design Quality Engineer

CY Partners are partnering with a growing and innovative diagnostics organisation to appoint a Design Quality Engineer into their Regulatory Affairs team.

This is a key role supporting the development of IVD products, with a strong focus on Design History File (DHF) ownership, design controls and audit-ready documentation. It is a great opportunity for someone who enjoys combining technical quality expertise with cross-functional collaboration in a fast-paced, project-driven environment.

The Opportunity

You will take ownership of DHFs from project initiation through to completion, ensuring all design and development activities are planned, documented and compliant with regulatory standards.

Working closely with the programme management function as well as the wider technical teams, you’ll play a central role in ensuring projects are delivered with robust traceability, strong documentation and right-first-time quality.

Key Responsibilities

• Own and manage the end-to-end DHF lifecycle for IVD projects
• Author and coordinate key documentation including design plans, inputs/outputs, verification & validation and design reviews
• Ensure full traceability across requirements, risks and testing activities
• Support and facilitate design reviews, ensuring clear documentation and action tracking
• Collaborate cross-functionally to ensure DHF deliverables align with project timelines
• Ensure compliance with ISO 13485, design control requirements and internal QMS processes
• Support audit readiness, including preparation of DHF evidence packs and participation in inspections
• Contribute to continuous improvement of SOPs, templates and quality processes

About You

• Degree qualified in a Life Sciences or related discipline
• Experience in Quality Engineering or Design Quality within medical devices or IVD
• Proven experience owning or contributing to Design History Files (DHF)
• Strong understanding of design controls and ISO 13485
• Confident working with controlled documentation systems (eQMS/SharePoint)
• Able to work cross-functionally and manage competing priorities in a fast-paced environment

Desirable experience includes:

Exposure to FDA 21 CFR 820 and/or IVDR/UKCA requirements

Risk management (ISO 14971) and audit support experience

This is a chance to join a business at an exciting stage of growth, where quality and regulatory excellence are central to product development. You’ll have real ownership, visibility across projects and the opportunity to contribute to impactful diagnostic programmes.

For more information or a confidential discussion, please get in touch.

CY Partners is acting as an Employment Agency in relation to this vacancy. Applicants must have the full right to work in the UK.