At a Glance
- Tasks: Own and improve the Quality Management System in a medical device company.
- Company: Join a close-knit team at a growing UK medical device manufacturer.
- Benefits: Up to £45,000 salary, 23 days holiday, health cash plan, and flexible working.
- Other info: Collaborative environment with opportunities for professional growth.
- Why this job: Make a real impact on patient safety and quality processes in healthcare.
- Qualifications: Experience in medical devices and knowledge of ISO 13485 required.
The predicted salary is between 45000 - 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.
Locations
Quality Engineer Medical Devices in Leeds, Yorkshire 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 product quality. With a strong focus on collaboration and continuous improvement, you'll enjoy a hands-on role within a close-knit environment that values your contributions and offers opportunities for professional growth. Benefit from a stable working atmosphere, competitive salary, and a health cash plan, all while making a tangible impact in the medical devices sector.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer Medical Devices in Leeds, Yorkshire
✨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 hunt for a Quality Engineer role. You never know who might have the inside scoop on job openings 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’re not just familiar but passionate about maintaining high-quality standards.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation for the opportunity. It keeps you fresh in their minds and shows your enthusiasm for the position.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team and contributing to the quality culture we value so much.
We think you need these skills to ace Quality Engineer Medical Devices in Leeds, Yorkshire
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 achievements related to ISO 13485 compliance. We want to see how your skills align with 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, and don’t forget to mention your relevant experience.
Showcase Your Problem-Solving Skills:In your application, be sure to highlight examples of how you've tackled quality issues in the past. We love candidates who can demonstrate their ability to conduct root cause analysis and implement effective CAPA strategies. Show us your analytical side!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the easiest 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 at StudySmarter!
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 the role. Be ready to discuss specific examples of how you've implemented or maintained quality management systems in previous positions. This will show that you’re not just familiar with the standards, but that you can actively contribute to compliance.
✨Showcase Your Problem-Solving Skills
Prepare to talk about your experience with CAPA and root cause analysis. Think of a couple of real-life scenarios where you identified a quality issue, investigated it, and implemented corrective actions. This will demonstrate your hands-on approach and ability to drive continuous improvement.
✨Familiarise Yourself with Regulatory Requirements
Since the role involves UKCA and CE marking, make sure you understand these regulations. Be prepared to discuss how you've navigated regulatory frameworks in the past and how you can ensure compliance in this new role. This shows that you’re proactive and knowledgeable about the industry.
✨Emphasise Team Collaboration
Given the collaborative nature of the team, be ready to share examples of how you've worked effectively with cross-functional teams. Highlight your communication skills and how you’ve contributed to a positive quality culture in previous roles. This will help convey that you’re a team player who values collaboration.
