At a Glance
- Tasks: Own and improve the Quality Management System while ensuring compliance with ISO 13485.
- 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: Dynamic role with opportunities for professional growth in a supportive environment.
- Why this job: Make a real impact in a collaborative team dedicated to quality in medical devices.
- Qualifications: Experience in medical devices and strong 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.
Quality Engineer Medical Devices in Manchester 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 meaningful impact in the medical devices sector.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer Medical Devices in Manchester
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Talent Finder. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Talent Finder.
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Talent Finder. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Talent Finder is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Quality Engineer Medical Devices in Manchester
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Talent Finder!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Talent Finder that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Talent Finder!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Talent Finder, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Talent Finder
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Talent Finder that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Talent Finder’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
