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- Tasks: Manage Design History Files and ensure compliance with regulatory standards in IVD product development.
- Company: Innovative diagnostics organisation focused on quality and regulatory excellence.
- Benefits: Opportunity for ownership, visibility across projects, and impactful contributions.
- Other info: Dynamic environment with strong focus on continuous improvement and career growth.
- Why this job: Join a growing team and make a real difference in diagnostic programmes.
- Qualifications: Experience in Quality Engineering or Design Quality within medical devices or IVD.
The predicted salary is between 40000 - 50000 £ per year.
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.
Quality and Design Engineer employer: CY Partners
Contact Detail:
CY Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality and Design Engineer
✨Tip Number 1
Network like a pro! Reach out to people in the diagnostics field, especially those who work in quality and design. Attend industry events or webinars, and don’t be shy about asking for informational interviews. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Show off your skills! Create a portfolio that highlights your experience with Design History Files and quality engineering. Include examples of documentation you've authored or projects you've managed. This will give potential employers a clear picture of what you bring to the table.
✨Tip Number 3
Prepare for interviews by brushing up on ISO 13485 and design controls. Be ready to discuss how you've ensured compliance in past roles. Use specific examples to demonstrate your expertise and how you can contribute to their team’s success.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got some fantastic opportunities waiting for you. Plus, applying directly shows your enthusiasm and commitment to joining our innovative team. Let’s get you that dream job!
We think you need these skills to ace Quality and Design Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality and Design Engineer role. Highlight your experience with Design History Files (DHF) and any relevant projects you've worked on. We want to see how your skills align with our needs!
Showcase Your Documentation Skills: Since this role involves a lot of documentation, be sure to showcase your experience with design controls and compliance with ISO 13485. Include examples of how you've managed documentation in past roles to demonstrate your expertise.
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read. We appreciate straightforward communication, especially in a fast-paced environment like ours!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at CY Partners
✨Know Your DHF Inside Out
Make sure you’re well-versed in the Design History File (DHF) process. Be ready to discuss your experience with DHFs, including how you've managed them from initiation to completion. Highlight specific examples where you ensured compliance with regulatory standards and maintained robust documentation.
✨Showcase Your Cross-Functional Collaboration Skills
This role requires a lot of teamwork, so be prepared to share instances where you’ve successfully collaborated with different teams. Talk about how you’ve facilitated design reviews or coordinated with programme management to meet project timelines, demonstrating your ability to work effectively in a fast-paced environment.
✨Demonstrate Your Understanding of ISO Standards
Familiarise yourself with ISO 13485 and ISO 14971, as these are crucial for the role. During the interview, confidently discuss how you’ve applied these standards in your previous roles, particularly in relation to design controls and risk management. This will show that you’re not just knowledgeable but also practical in applying these regulations.
✨Prepare for Audit Readiness Questions
Since audit support is part of the job, be ready to talk about your experience with preparing for audits and inspections. Share specific examples of how you’ve contributed to audit readiness, such as preparing evidence packs or participating in inspections, to demonstrate your proactive approach to quality assurance.