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- Tasks: Support quality processes for medical devices and drive investigations on manufacturing issues.
- Company: Dynamic Medtech company focused on high-quality standards.
- Benefits: Competitive salary, career growth, and a chance to make a real impact.
- Other info: Opportunity to work cross-functionally and participate in audits.
- Why this job: Join a fast-paced environment and contribute to life-saving medical innovations.
- Qualifications: Experience with Class IIb/III devices and strong knowledge of ISO standards.
The predicted salary is between 40000 - 50000 £ per year.
We’re looking for a hands-on Quality / Manufacturing Engineer with strong experience in Class IIb/III medical devices to join a growing and dynamic team. This role is ideal for someone who thrives in regulated environments and enjoys working cross-functionally across production, quality, and suppliers.
Key Responsibilities
- Support manufacturing and quality processes for sterile medical devices
- Drive root cause investigations for manufacturing-related issues
- Manage and support CAPA, non-conformances, and complaints
- Work closely with production teams and external suppliers
- Lead and support change control processes
- Contribute to process validation and risk management activities
- Review and update SOPs and work instructions
- Participate in internal and external audits (front & back office)
Essential Requirements
- Experience with Class IIb/III devices
- Strong knowledge of ISO 13485 and 21 CFR 820
- Background working for a legal manufacturer or subcontract manufacturer
- Understanding of: QC & GD&T on drawings, Process risk management & validation
- Experience liaising with suppliers and production teams
- Proven audit experience (internal & external)
Desirable
- Validation protocol authoring
- Experience setting up new production lines/processes
- Exposure to additive manufacturing
- Engineering background
- Lead auditor training
- Experience in a start-up environment
- Authorship of procedures
If you’re looking to make an impact in a high-quality, fast-paced Medtech environment, apply or reach out directly to learn more.
Quality Engineer in London employer: Discover International
Contact Detail:
Discover International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry, especially those who work with Class IIb/III devices. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on ISO 13485 and 21 CFR 820. We want you to showcase your knowledge of quality processes and regulations, so practice explaining how you've applied these in past roles.
✨Tip Number 3
Don’t just wait for job postings! Be proactive and reach out directly to companies you're interested in. Express your enthusiasm for their work in the Medtech space and ask if they have any upcoming opportunities.
✨Tip Number 4
When you apply through our website, make sure to highlight your experience with CAPA and non-conformances. Tailor your application to show how you can contribute to their quality and manufacturing processes.
We think you need these skills to ace Quality Engineer in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Engineer role. Highlight your experience with Class IIb/III medical devices and any relevant ISO 13485 knowledge. We want to see how your background fits perfectly with 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 quality engineering in the Medtech field. Share specific examples of how you've tackled challenges in regulated environments, as this will resonate with us.
Showcase Your Cross-Functional Experience: Since this role involves working closely with production teams and suppliers, make sure to highlight any cross-functional projects you've been part of. We love seeing how you collaborate and drive results across different teams!
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 dynamic team at StudySmarter!
How to prepare for a job interview at Discover International
✨Know Your Stuff
Make sure you brush up on your knowledge of Class IIb/III medical devices and ISO 13485. Be ready to discuss specific examples from your past experience that demonstrate your understanding of these regulations and how you've applied them in real-world scenarios.
✨Showcase Your Problem-Solving Skills
Prepare to talk about your experience with root cause investigations and CAPA management. Think of a couple of situations where you successfully identified issues and implemented solutions, as this will show your hands-on approach and ability to thrive in regulated environments.
✨Cross-Functional Collaboration
Since the role involves working closely with production teams and suppliers, be ready to share examples of how you've effectively collaborated across different departments. Highlight any experiences where you led change control processes or contributed to process validation activities.
✨Audit Experience is Key
Given the importance of audits in this role, prepare to discuss your audit experience, both internal and external. If you've been involved in authoring procedures or participating in audits, make sure to mention these experiences to demonstrate your thorough understanding of quality systems.