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For Companies At a Glance
- Tasks: Manage quality processes and ensure compliance with industry standards in a medical device company.
- Company: Join a leading medical device manufacturer committed to quality and innovation.
- Benefits: Competitive salary, hands-on experience, and opportunities for professional growth.
- Why this job: Make a real impact on quality management and continuous improvement in healthcare.
- Qualifications: Experience in quality functions and knowledge of ISO 13485 required.
- Other info: Dynamic role with exposure to audits, complaints, and cross-functional collaboration.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent are delighted to be partnered with a medical device manufacturer as they look to strengthen their Quality function. We have an exciting opportunity for a Quality System Engineer to join the team and take ownership of day‑to‑day quality processes within an established Quality Management System. As the new Quality System Engineer, you will be responsible for managing and maintaining core quality processes, supporting compliance with ISO 13485 and MDR requirements, and driving continuous improvement across the business. Reporting into the Quality Director, this is a hands‑on role with broad exposure across audits, complaints, non‑conformances, and GMP activities.
Key Responsibilities
- Manage and maintain the Quality Management System, ensuring ongoing compliance with applicable standards.
- Oversee document control, including release, archiving, and maintenance of controlled documentation.
- Manage non‑conformances, supplier corrective actions, and root cause investigations.
- Coordinate customer complaint investigations and generate technical reports as required.
- Oversee internal, external, and supplier audits, ensuring actions are assigned and completed effectively.
- Support deviation management and GMP review of manufacturing and quality records.
- Provide training and quality induction to ensure company‑wide understanding of quality procedures.
- Support Management Review and Quality Improvement Review activities with data analysis and reporting.
- Act as deputy for PRRC responsibilities in the absence of the Quality Director.
Experience And Skills Required
- Experience working within a Quality function in the medical device industry.
- Practical experience and training in ISO 13485.
- Degree‑qualified in a relevant discipline.
- Knowledge of MDR 2017/745 and FDA 21 CFR Part 820 is advantageous.
- Strong organisational skills, attention to detail, and ability to work cross‑functionally.
If you’re a Quality professional looking for a hands‑on role focused on QMS ownership, compliance, and continuous improvement within a medical device environment, we’d love to hear from you.
Quality System Engineer - Cure Talent employer: Jobster
Contact Detail:
Jobster Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality System Engineer - Cure Talent
✨Tip Number 1
Network like a pro! Reach out to people in the medical device industry, especially those who work in quality roles. 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 MDR requirements. We want you to be ready to discuss how your experience aligns with the role. Show them you know your stuff!
✨Tip Number 3
Don’t just apply and wait! Follow up on your applications. A quick email to express your enthusiasm can keep you top of mind for hiring managers.
✨Tip Number 4
Check out our website for the latest job postings. We’re always updating our listings, and applying directly through us can give you an edge over other candidates!
We think you need these skills to ace Quality System Engineer - Cure Talent
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality System Engineer role. Highlight your experience in managing quality processes and compliance with ISO 13485, as these are key for us at Cure Talent.
Showcase Relevant Experience: When writing your cover letter, focus on your practical experience in the medical device industry. Mention specific projects or responsibilities that align with the job description to catch our eye.
Be Clear and Concise: Keep your application clear and to the point. Use bullet points where possible to make it easy for us to see your qualifications and achievements at a glance.
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. It helps us keep track of applications and ensures you’re considered for the Quality System Engineer position!
How to prepare for a job interview at Jobster
✨Know Your Standards
Make sure you brush up on ISO 13485 and MDR requirements before the interview. Being able to discuss these standards confidently will show that you understand the core of the role and are ready to take ownership of the Quality Management System.
✨Showcase Your Experience
Prepare specific examples from your past work in quality functions, especially within the medical device industry. Highlight your involvement in managing non-conformances, conducting audits, or leading root cause investigations to demonstrate your hands-on experience.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle certain situations, like a customer complaint or a non-conformance issue. Think through your approach and be ready to explain your thought process and the steps you would take to resolve these issues effectively.
✨Emphasise Continuous Improvement
Discuss any initiatives you've led or been part of that focused on quality improvement. This could include training sessions, process enhancements, or data analysis for management reviews. Showing your commitment to continuous improvement will resonate well with the interviewers.
