At a Glance
- Tasks: Ensure our Quality Management System meets global medical device regulations and supports continuous improvement.
- Company: Smith+Nephew, a leader in innovative medical technology.
- Benefits: Generous bonuses, flexible work, health plans, and employee discounts.
- Other info: Join a culture of inclusion and growth with excellent career development opportunities.
- Why this job: Make a real impact on patient safety and product quality in a dynamic environment.
- Qualifications: Experience in Quality Assurance within medical devices and strong analytical skills.
The predicted salary is between 40000 - 50000 £ per year.
About the Role
Life. Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living. Quality sits at the heart of everything we do. As a QMS Specialist, you will play a critical role in ensuring our Quality Management System continues to meet global medical device regulations while evolving to support continuous improvement. This is an opportunity to make a real impact in a highly regulated environment, working closely with experts across the business to protect patients, strengthen compliance and drive operational excellence.
Responsibilities
- You will be a trusted quality partner within the Hull site, owning and supporting key Quality Management System processes and helping the organisation stay audit ready at all times.
- Your work will span maintaining and improving core QMS processes, interpreting evolving regulatory requirements and translating them into practical, effective solutions.
- You will collaborate with cross‑functional teams, support internal and external audits and use data and root‑cause analysis to identify trends, risks and opportunities for improvement.
- Every day, your focus will be on strengthening systems that enable safe, compliant and high‑quality products for patients around the world.
Qualifications
- Solid experience within Quality Assurance in the medical device or pharmaceutical industry, with working knowledge of ISO 13485, MDR and FDA 21 CFR Part 820.
- Hands‑on experience owning or supporting key QMS processes such as CAPA, document control, change control, training, non‑conformance or audit management.
- The ability to analyse data, identify trends and apply root‑cause and continuous improvement methodologies to drive meaningful change.
- Clear communication and stakeholder engagement skills, enabling you to influence, train and support teams across the organisation.
Benefits
- Inclusion and Belonging: Committed to welcoming, celebrating and thriving on inclusion and belonging.
- Your Future: Generous annual bonus and pension schemes, Save as You Earn share options.
- Work/Life Balance: Flexible vacation and time off, paid holidays and paid volunteering hours.
- Your Wellbeing: Private health and dental plans, healthcare cash plans, income protection, life assurance and much more.
- Flexibility: Hybrid working model for most professional roles.
- Training: Hands‑on, team‑customised, mentorship.
- Extra Perks: Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes and many other employee discounts.
You. Unlimited.
QMS Specialist employer: Smith+Nephew
At Smith+Nephew, we pride ourselves on being an exceptional employer, particularly for our QMS Specialist role in Hull. Our commitment to inclusion and belonging fosters a supportive work culture where every employee can thrive, while our generous benefits package, including flexible working arrangements and comprehensive health plans, ensures a healthy work-life balance. With ample opportunities for professional growth through tailored training and mentorship, you will be empowered to make a meaningful impact in the medical device industry.
