At a Glance
- Tasks: Own and manage Design History Files for innovative diagnostic products.
- 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, project-driven environment.
- 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.
Product Quality Engineer employer: CY Partners
Join a dynamic and innovative diagnostics organisation that prioritises quality and regulatory excellence in product development. As a Product 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 diagnostic programmes, you'll enjoy the benefits of working in a fast-paced environment where your contributions are recognised and valued.
StudySmarter Expert Advice🤫
We think this is how you could land Product 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 answers to common interview questions, especially those related to design controls and compliance. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your achievements.
✨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 are proactive about their job search.
We think you need these skills to ace Product Quality Engineer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Product Quality Engineer role. Highlight your experience with Design History Files and any relevant projects you've worked on. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality engineering in diagnostics. Share specific examples of your work that demonstrate your expertise in design controls and compliance.
Showcase Your Collaboration Skills:Since this role involves cross-functional collaboration, make sure to mention any experiences where you’ve worked with different teams. We love seeing how you can bring people together to achieve project goals!
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, it shows you’re keen on joining our team at StudySmarter!
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 prepared 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 ready 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. Emphasise your ability to communicate effectively across functions.
✨Demonstrate Your Understanding of ISO Standards
Familiarise yourself with ISO 13485 and ISO 14971, as these are crucial for the role. During the interview, mention how you’ve applied these standards in your previous work. Discuss any experiences you have with audit readiness and how you prepared documentation for inspections.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think of challenges you’ve faced in quality engineering or design controls and how you overcame them. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly and effectively.
