At a Glance
- Tasks: Manage Design History Files and ensure compliance with regulatory standards in IVD projects.
- Company: Join a growing diagnostics organisation focused on quality and innovation.
- 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: Be part of a fast-paced environment where your expertise makes a difference.
- 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 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.
Design Quality Engineer employer: CY Partners
CY Partners is an exceptional employer, offering a dynamic work environment where innovation and quality are at the forefront of product development. As a Design Quality Engineer, you will benefit from a collaborative culture that encourages professional growth and provides opportunities to contribute to impactful diagnostic programmes. With a strong focus on regulatory excellence and continuous improvement, this role offers the chance to make a meaningful difference in the healthcare sector while enjoying the support of a dedicated team.
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 researching the company and its products. Understand their design quality processes and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate!
✨Tip Number 3
Practice your responses to common interview questions, especially those related to design controls and compliance. We recommend doing mock interviews with friends or using online resources to boost your confidence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Design Quality Engineer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Design Quality Engineer role. Highlight your experience with Design History Files and any relevant quality engineering skills. We want to see how your background aligns 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 standards like ISO 13485. We love seeing examples of your audit-ready documentation!
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 see your key achievements and skills. We appreciate straightforward communication!
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. We can’t wait to hear from you!
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) lifecycle. Be prepared to discuss your previous experiences managing DHFs, including how you ensured compliance with regulatory standards and maintained traceability. This will show your potential employer 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 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 be crucial in showcasing your expertise.
✨Prepare for Audit Readiness Questions
Expect questions about your experience with audit support and preparation of evidence packs. Think of specific instances where you contributed to audit readiness and how you managed documentation systems. This will help you stand out as a candidate who understands the importance of compliance and quality assurance.
