At a Glance
- Tasks: Maintain and improve the ISO 13485 QMS while supporting product development and regulatory activities.
- Company: Fast-growing MedTech innovator focused on next-gen medical devices.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Hands-on role with exciting challenges in a cutting-edge environment.
- Why this job: Join a dynamic team and make a real impact in the medical device industry.
- Qualifications: 2+ years in medical device quality with strong knowledge of ISO 13485.
The predicted salary is between 40000 - 50000 € 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 & risk management
- Background in medical devices (Class II/III preferred)
- Additive manufacturing / 3D printing experience would be highly beneficial
Quality Engineer in London employer: Lynx Recruitment
As a leading MedTech innovator, we pride ourselves on fostering a dynamic and collaborative work environment where Quality Engineers can thrive. Our commitment to employee growth is evident through continuous training opportunities and hands-on involvement in cutting-edge projects, all while being part of a team that values innovation and quality in the development of next-generation medical devices. Located in a vibrant area, we offer a unique chance to contribute to meaningful advancements in healthcare while enjoying a supportive culture that prioritises work-life balance.
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 folks in the MedTech industry, especially those who work with ISO 13485. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Show off your skills! When you get the chance to meet potential employers, be ready to discuss your experience with CAPAs and change control. Real-life examples can make you stand out from the crowd.
✨Tip Number 3
Don’t shy away from asking questions during interviews. Inquire about their QMS processes or how they handle regulatory audits. It shows you're genuinely interested and knowledgeable about the role.
✨Tip Number 4
Apply through our website! We’ve got loads of resources to help you prepare for interviews and connect with the right people in the industry. Let’s get you that Quality Engineer role!
We think you need these skills to ace Quality Engineer in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in medical device quality and ISO 13485. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects or achievements!
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 space and how your skills can contribute to our innovative team. Keep it engaging and personal!
Showcase Your Technical Skills:We’re looking for someone with strong knowledge of design controls and risk management. Be sure to mention any specific tools or methodologies you’ve used in your previous roles that relate to these areas.
Apply Through Our Website:We encourage you to apply directly 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!
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. Be ready to discuss specific examples of how you've maintained or improved a QMS in your previous roles.
✨Showcase Your Hands-On Experience
Since this is a hands-on role, be prepared to share detailed experiences from your past work. Talk about your involvement in document control, CAPAs, and change control processes, and how these contributed to successful product launches.
✨Prepare for Technical Questions
Expect technical questions related to design controls, risk management, and regulatory compliance. Brush up on the latest regulations like MDR and 21 CFR 820, and think of scenarios where you applied this knowledge in real-world situations.
✨Highlight Collaboration Skills
This role requires working closely with engineering and clinical teams, so be ready to discuss how you've successfully collaborated in the past. Share examples of how you’ve facilitated communication between departments to ensure quality standards are met.
