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-generation medical devices.
- Benefits: Competitive salary, hands-on experience, and opportunities for professional growth.
- Other info: Exciting environment with a focus on cutting-edge additive manufacturing.
- 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)
- Additive manufacturing / 3D printing experience would be highly beneficial
Quality Engineer in London employer: LinkedIn
As a Quality Engineer at our fast-growing MedTech company, you'll be part of an innovative team dedicated to developing next-generation medical devices. We offer a collaborative work culture that prioritises employee growth through hands-on experience and continuous learning opportunities, all while being located in a vibrant area that fosters creativity and innovation in the healthcare sector.
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 professionals in the MedTech field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Quality Engineer role.
✨Tip Number 2
Prepare for interviews by brushing up on ISO 13485 and other relevant regulations. We recommend creating a cheat sheet of key points and examples from your experience that showcase your knowledge and skills.
✨Tip Number 3
Showcase your hands-on experience with quality management systems. We suggest bringing specific examples of how you’ve improved processes or handled CAPAs in past roles to the table during interviews.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
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 ISO 13485 and any relevant projects you've worked on in the medical device field. 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 quality engineering in MedTech and how your background aligns with our mission at StudySmarter. Keep it concise but impactful!
Showcase Relevant Experience:When filling out your application, be sure to showcase your experience with document control, CAPAs, and change control. We love seeing candidates who can demonstrate their hands-on experience in maintaining a QMS.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at LinkedIn
✨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 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 with cross-functional teams in the past. Share examples that demonstrate your communication skills and ability to work towards common goals.
