At a Glance
- Tasks: Own and manage Design History Files for innovative diagnostic projects.
- Company: Join a growing diagnostics organisation focused on quality and regulatory excellence.
- Benefits: Gain real ownership, visibility across projects, and contribute to impactful programmes.
- Other info: Exciting growth stage with opportunities for continuous improvement and career development.
- Why this job: Combine technical expertise with collaboration in a fast-paced environment.
- Qualifications: Degree in Life Sciences and experience in Quality Engineering or Design Quality.
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.
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
- 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.
Design Quality Engineer employer: Cypartners
Join a dynamic and innovative diagnostics organisation that prioritises quality and regulatory excellence in product development. As a Design Quality Engineer, you will thrive in a collaborative work culture that values your expertise and offers ample opportunities for professional growth. With a focus on impactful projects and a commitment to continuous improvement, this role provides a unique chance to make a significant difference in the field of diagnostics while enjoying a supportive and fast-paced environment.
StudySmarter Expert Advice🤫
We think this is how you could land Design Quality Engineer
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by practising common questions and showcasing your experience with Design History Files and ISO standards. We recommend doing mock interviews with friends or using online resources to boost your confidence.
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from the interview to show your genuine interest in the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Design Quality Engineer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Design Quality Engineer role. Highlight your experience with Design History Files and any relevant regulatory standards like ISO 13485.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're passionate about quality engineering in the diagnostics field. Share specific examples of how you've contributed to design controls or audit-ready documentation in past roles.
Showcase Your Collaboration Skills:Since this role involves cross-functional collaboration, mention instances where you've successfully worked with different teams. We want to see how you can bring people together to achieve project goals.
Apply Through Our Website:For the best chance of getting noticed, apply directly through our website. It helps us keep track of applications and ensures you’re considered for this exciting opportunity!
How to prepare for a job interview at Cypartners
✨Know Your DHF Inside Out
Make sure you’re well-versed in the Design History File (DHF) lifecycle. Be prepared to discuss your previous experiences managing DHFs, including how you ensured compliance with regulatory standards and maintained traceability. This will show that you understand the core responsibilities of the role.
✨Showcase Your Cross-Functional Collaboration Skills
Since this role involves working closely with various teams, think of examples where you successfully collaborated across functions. Highlight how you’ve facilitated design reviews or coordinated documentation efforts, as this will demonstrate your ability to thrive in a project-driven environment.
✨Brush Up on ISO Standards
Familiarise yourself with ISO 13485 and other relevant regulations like FDA 21 CFR 820. Be ready to discuss how you’ve applied these standards in your past roles, especially in relation to quality engineering and design controls. This knowledge will set you apart as a candidate who is serious about compliance.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations related to design controls or audit readiness. Think through potential challenges you might face in the role and how you would address them. This preparation will help you convey your problem-solving skills effectively during the interview.
