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- Tasks: Ensure product quality and compliance in the medical device manufacturing process.
- Company: Join a growing medical device organisation in London with a focus on innovation.
- Benefits: Competitive salary, hands-on experience, and opportunities for professional growth.
- Why this job: Make a real difference in healthcare by ensuring the quality of life-saving devices.
- Qualifications: Experience in medical devices and knowledge of ISO standards required.
- Other info: Dynamic team environment with potential for career advancement.
The predicted salary is between 30000 - 40000 £ per year.
We’re supporting a growing medical device organisation seeking an experienced Quality / Manufacturing Engineer to join their team. This role will play a key part in ensuring product quality, regulatory compliance, and manufacturing excellence across sterile, high-risk devices.
Key Responsibilities
- Support manufacturing and quality activities for Class IIb / III medical devices
- Ensure compliance with ISO 13485 and 21 CFR Part 820
- Work closely with legal manufacturers and/or contract manufacturing partners
- Collaborate with production teams and external suppliers on quality and process improvements
- Lead and support root cause investigations for manufacturing-related issues
- Manage CAPAs, non-conformances, and complaints
- Support and maintain change control processes
- Review and update procedures and work instructions
- Contribute to internal and external audit activities
Essential Experience
- Strong background in medical devices
- Working knowledge of ISO 13485 and 21 CFR 820
- Experience working with legal manufacturers or subcontract manufacturers
- Understanding of QC processes and GD&T on engineering drawings
- Knowledge of process risk management and process validation
- Hands-on experience with CAPA, non-conformances, and complaint handling
- Experience liaising with production teams and/or external suppliers
- Experience with change control systems
- Internal and external audit experience
Desirable Skills
- Validation protocol authoring
- Experience setting up new production lines or processes
- Exposure to additive manufacturing
- Experience authoring procedures
- Engineering background
- Lead auditor training
- Previous experience in a start-up environment
~ Must be within a reasonable commuting distance (~1 hour) of South Kensington
Graduate Engineer / Quality Engineer in London employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Graduate Engineer / Quality Engineer in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device industry on LinkedIn or at local events. We can’t stress enough how personal connections can lead to job opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and 21 CFR Part 820. We recommend creating a cheat sheet with key points and examples from your experience to showcase your expertise during the interview.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest using our website to find roles that excite you, especially in quality and manufacturing engineering within the medical devices sector.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can set you apart from other candidates. We believe it shows your enthusiasm for the role and keeps you fresh in their minds.
We think you need these skills to ace Graduate Engineer / Quality Engineer in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of a Quality Engineer. Highlight your experience with medical devices, ISO standards, and any relevant projects you've worked on. 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 in medical devices and how your skills align with our needs. We love seeing genuine enthusiasm, so let your personality come through!
Showcase Relevant Experience: When filling out your application, be sure to showcase your hands-on experience with CAPAs, non-conformances, and audits. We’re keen on candidates who can demonstrate their understanding of quality processes and regulatory compliance.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application directly. Plus, it shows you’re serious about joining our team. We can’t wait to hear from you!
How to prepare for a job interview at Barrington James
✨Know Your Standards
Familiarise yourself with ISO 13485 and 21 CFR Part 820 before the interview. Being able to discuss these standards confidently will show that you understand the regulatory landscape of medical devices, which is crucial for the role.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience with CAPAs, non-conformances, and complaint handling. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Collaborative Mindset
Emphasise your ability to work closely with production teams and external suppliers. Think of instances where you’ve successfully collaborated on quality improvements or process enhancements, as this will demonstrate your teamwork skills.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s quality processes and how they handle audits. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your career goals.