At a Glance
- Tasks: Own and improve the Quality Management System in a dynamic medical devices environment.
- Company: Join a growing UK medical device manufacturer focused on quality and patient safety.
- Benefits: Up to £45,000 salary, 23 days holiday, health cash plan, and flexible working options.
- Other info: Opportunity for career growth in a supportive and innovative environment.
- Why this job: Make a real impact on quality processes and compliance in a collaborative team.
- Qualifications: Experience in medical devices and strong knowledge of ISO 13485 required.
The predicted salary is between 42000 - 45000 £ per year.
This is a hands-on Quality Engineer role within a specialist UK medical device manufacturer, where quality, compliance, and patient safety are central to everything the business does. You will be joining a close-knit Quality & Regulatory team within a small but growing organisation of around 40 employees, working alongside experienced quality professionals and with support from a QA/RA leadership structure. The environment is collaborative and highly involved, with strong exposure to both manufacturing operations and quality system ownership.
The role sits at the heart of maintaining and continuously improving a well-established Quality Management System (QMS), with a strong focus on ISO 13485 compliance and ongoing adherence to UKCA and CE marking requirements. You will take ownership of day-to-day quality activities including document control, non-conformance management, CAPA, and audit preparation, while also supporting both internal and external audits. Alongside this, you will contribute to continuous improvement initiatives and help strengthen quality processes across the business.
This position is best suited to someone with direct medical device industry experience who is confident working within a regulated manufacturing environment. Given the size of the organisation, this is a highly visible role where you will be trusted with real ownership and the opportunity to make a tangible impact. The business is also open to considering strong mid-level candidates who are looking to further develop within a supportive medical devices environment.
What will your role look like?
- Owning and maintaining the Quality Management System (QMS) in line with ISO 13485
- Ensuring quality processes, procedures and documentation remain compliant and effective
- Supporting UKCA, CE and MDR regulatory compliance activities and technical documentation
- Leading and supporting investigations into non-conformances, complaints and quality issues
- Carrying out root cause analysis and implementing effective corrective and preventive actions (CAPA)
- Supporting internal and external audits, including preparation, participation and follow-up actions
- Monitoring quality data and trends to identify risks and drive continuous improvement
- Supporting supplier approval, monitoring and ongoing quality performance
- Assisting with validation activities and production quality verification where required
- Working closely with manufacturing and cross-functional teams to ensure product quality is maintained
- Supporting the QA/RA Director with departmental workload and compliance priorities
- Contributing to a proactive, improvement-led quality culture across the business
Are you the right person for the job?
- Proven experience within the Medical Devices industry (essential)
- Strong working knowledge of ISO 13485 and Quality Management Systems
- Around 5 years experience in a quality-related role (flexible for the right candidate)
- Confident working with QMS processes such as CAPA, document control, change control, deviations and NCRs
- Experience supporting or leading internal and external audits
- Exposure to MDR 2017/745 / UK MDR requirements
- Understanding of regulatory frameworks including UK MDR, EU MDR/CE and UKCA
- Experience in root cause analysis and quality investigations
- Degree in a scientific, engineering or related discipline (or equivalent experience)
- UK-based with existing right to work (sponsorship not preferred)
What's in it for you?
- Opportunity to work in a true Medical Devices environment with full exposure to ISO 13485 systems
- Small, collaborative team where your input directly shapes quality processes and compliance standards
- Hands-on role with visibility across manufacturing, quality systems, and regulatory activity
- 23 days holiday plus bank holidays
- HealthShield Classic health cash plan (post-probation) supporting dental, optical and wellbeing costs
- Stable working environment with a strong focus on quality and continuous improvement
- Occasional ad hoc flexibility to work from home where appropriate
What's next?
It's easy! Click APPLY now! We can't wait to hear from you! Your data will be handled in line with GDPR.
Quality Engineer Medical Devices employer: Talent Finder
Join a dynamic and supportive team at a specialist UK medical device manufacturer in Leeds, where your expertise as a Quality Engineer will directly influence patient safety and compliance. With a strong focus on ISO 13485 and a collaborative work culture, you'll have the opportunity to take ownership of quality processes while benefiting from a stable environment that encourages professional growth and continuous improvement. Enjoy a hands-on role with visibility across operations, alongside competitive benefits including a health cash plan and flexible working options.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer Medical Devices
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical devices industry and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on ISO 13485 and quality management systems. Be ready to discuss your hands-on experience with CAPA and audits, as these are key topics for the role. Show them you know your stuff!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise. Use our website to find roles that excite you and match your skills. Tailor your approach to each company to stand out!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to show your genuine interest in the role and the company.
We think you need these skills to ace Quality Engineer Medical Devices
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience in the medical devices industry and any specific knowledge of ISO 13485. 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 in medical devices and how you can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Relevant Experience:When filling out your application, be sure to showcase your relevant experience with QMS processes like CAPA and document control. We’re keen on seeing how you've tackled challenges in previous roles, so don’t hold back!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy!
How to prepare for a job interview at Talent Finder
✨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 implemented or maintained compliance in previous roles.
✨Showcase Your Problem-Solving Skills
Prepare to share concrete examples of how you've tackled non-conformances or quality issues in the past. Highlight your experience with root cause analysis and CAPA processes, as this will demonstrate your hands-on approach to quality engineering.
✨Familiarise Yourself with Regulatory Requirements
Get a good grasp of UKCA, CE marking, and MDR requirements. Being able to discuss these regulations confidently will show that you're not just familiar with the standards but also understand their implications for quality processes.
✨Emphasise Team Collaboration
Since the role involves working closely with cross-functional teams, be prepared to talk about your experience in collaborative environments. Share examples of how you've contributed to a proactive quality culture and supported team initiatives.
