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.
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.
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
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) 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….