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- Tasks: Maintain and improve ISO 13485 QMS while supporting product development and regulatory activities.
- Company: Fast-growing MedTech innovator focused on next-gen medical devices.
- Benefits: Competitive salary, hands-on experience, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on cutting-edge additive manufacturing.
- Why this job: Join a dynamic team making a real difference in healthcare innovation.
- Qualifications: 2+ years in medical device quality with knowledge of ISO 13485 and design controls.
The predicted salary is between 35000 - 45000 £ per year.
Join a fast-growing, MedTech innovator developing next-generation Medical Devices using cutting-edge additive manufacturing. This is a hands-on Quality Engineer role where you’ll play a key part in maintaining and improving an ISO 13485 QMS while supporting product development, validation, and regulatory activities ahead of major commercial launches.
What you’ll be doing:
- Own and maintain the QMS (ISO 13485)
- Manage document control, CAPAs, and change control
- Support NPD, validation, and testing activities
- Conduct internal audits and support external/regulatory audits
- Work closely with engineering and clinical teams
What we’re looking for:
- 2+ years in medical device quality
- Strong knowledge of ISO 13485, MDR, and/or 21 CFR 820
- Experience with design controls
Quality Engineer employer: Lynx Recruitment
Contact Detail:
Lynx Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer
✨Tip Number 1
Network like a pro! Reach out to folks in the MedTech industry on LinkedIn or at local meetups. We all know that sometimes it’s not just what you know, but who you know that can help you land that Quality Engineer role.
✨Tip Number 2
Prepare for those interviews by brushing up on ISO 13485 and other relevant regulations. We suggest creating a cheat sheet of key points and examples from your experience that showcase your knowledge and skills in quality management systems.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We recommend mentioning something specific from your conversation to show you were engaged and interested.
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it’s super easy to keep track of your applications this way!
We think you need these skills to ace Quality Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Engineer role. Highlight your experience with ISO 13485 and any relevant projects you've worked on. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about MedTech and how your background in quality engineering makes you a perfect fit for our team. Let us know what excites you about this role!
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! If you've improved processes or led successful audits, we want to hear about it. Numbers and specific examples can really make your application stand out.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Lynx Recruitment
✨Know Your ISO 13485 Inside Out
Make sure you brush up on your knowledge of ISO 13485 and how it applies to quality management systems in the medical device industry. Be ready to discuss specific examples of how you've implemented or maintained a QMS in your previous roles.
✨Showcase Your Hands-On Experience
This role is all about being hands-on, so prepare to share concrete examples of your experience with document control, CAPAs, and change control. Think of situations where you made a significant impact and be ready to explain your thought process.
✨Prepare for Technical Questions
Expect technical questions related to NPD, validation, and testing activities. Brush up on your design controls knowledge and be prepared to discuss how you've supported product development in the past. This will show that you can hit the ground running.
✨Demonstrate Team Collaboration Skills
Since you'll be working closely with engineering and clinical teams, think of examples that highlight your ability to collaborate effectively. Be ready to discuss how you’ve navigated challenges in cross-functional teams and contributed to successful outcomes.