At a Glance
- Tasks: Dive into the real-world challenges of bringing medical devices to market.
- Company: Exciting early-stage medical device company based in London.
- Benefits: Opportunity to shape quality processes and make a real impact.
- Other info: Join a dynamic team and contribute to key milestones like product launch.
- Why this job: Be at the forefront of innovation in the medical device industry.
- Qualifications: Experience with Class II/III medical devices and strong quality management skills.
The predicted salary is between 45000 - 55000 £ per year.
If you enjoy getting stuck into the reality of how a medical device actually gets to market, keep reading. I’m working with an early stage Medical Device company based in London. They’re pre-commercial, with a Class II/III product, targeting US entry by the end of this year. This isn’t just maintaining a system; instead, you’ll be right in the middle of getting this product ready for market. That includes:
- Owning CAPA, NCs, and root cause investigations
- Managing change control across product and process
- Supporting process validation (with fully outsourced manufacturing)
- Working closely with suppliers
- Building and improving parts of the QMS as the business scales
- Supporting internal and external audits
- Helping shape final QA release processes
You’ll also be close to key milestones like:
- 510(k) submission
- ISO 13485 certification
- Supplier audit programmes
- Product launch
For this role to land, the business needs someone who understands manufacturing quality in medical devices. You’ll likely have:
- Experience in Class II/III medical devices
- Exposure to ISO 13485 and ideally 21 CFR 820
- Strong CAPA, root cause, and change control experience
- Experience working with suppliers or outsourced manufacturing
If you’ve worked in a smaller or scaling environment before, that’s a big plus. If you’re someone who enjoys being in the detail but also wants to make a genuine impact, this is a really interesting one. Message me directly or apply below and I’ll talk you through the full picture.
Quality Engineer in London employer: Medibeam
Contact Detail:
Medibeam 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 people in the medical device 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 your CAPA and root cause analysis skills. We recommend having specific examples ready to showcase your experience with Class II/III devices. This will show them you’re the real deal!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that excite you! We suggest checking out our website for roles that match your passion for quality in medical devices. Tailor your approach to each company’s mission and values.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way. We believe it shows your enthusiasm and professionalism, which is key in the medical device field. Plus, it keeps you fresh in their minds!
We think you need these skills to ace Quality Engineer in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV speaks directly to the role of Quality Engineer. Highlight your experience with Class II/III medical devices and any relevant ISO standards. We want to see how your background aligns with what we're looking for!
Showcase Your Experience: When writing your cover letter, don’t just list your skills. Share specific examples of how you've owned CAPA, managed change control, or worked with suppliers. We love seeing real-life applications of your expertise!
Be Authentic: Let your personality shine through in your application. We’re looking for someone who’s not just qualified but also a good fit for our team culture. Don’t be afraid to show us what makes you unique!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re genuinely interested in joining our team!
How to prepare for a job interview at Medibeam
✨Know Your QMS Inside Out
Make sure you’re familiar with Quality Management Systems, especially in the context of medical devices. Brush up on ISO 13485 and 21 CFR 820, as these will likely come up during your interview. Being able to discuss how you've applied these standards in previous roles will show that you’re ready to hit the ground running.
✨Prepare for CAPA and Root Cause Questions
Since this role involves owning CAPA and root cause investigations, be prepared to share specific examples from your past experiences. Think about challenges you faced, how you approached them, and what the outcomes were. This will demonstrate your problem-solving skills and your ability to manage quality issues effectively.
✨Show Your Supplier Management Skills
The job requires working closely with suppliers, so be ready to discuss your experience in managing supplier relationships. Highlight any successful collaborations or improvements you’ve made in the past. This will show that you understand the importance of quality throughout the supply chain.
✨Emphasise Your Impact in Smaller Environments
If you’ve worked in smaller or scaling companies before, make sure to highlight this experience. Talk about how you contributed to building or improving processes and systems. This will resonate well with the company’s current stage and their need for someone who can make a genuine impact.