Maintain and improve the Quality Management System, ensure audit readiness, interpret regulatory requirements (ISO 13485, MDR, FDA 21 CFR 820), support CAPA, document and change control, training and nonconformance processes, collaborate cross-functionally, support internal/external audits, and use data and root cause analysis to drive continuous improvement.
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.
What will you be doing?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.
What will you need to be successful?Success in this role comes from combining strong technical quality knowledge with a practical, improvement focused mindset. You will bring:
- 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.
You. Unlimited.
We believe in creating the greatest good for society. Our Strongest investments are in our people and patients we serve.
Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about our Employee Inclusion Groups on our website (www.smith-nephew.com)
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, so we can give back to our communities!
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.
We believe in creating the greatest good for society. Our Strongest investments are in our people and patients we serve.
Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about our Employee Inclusion Groups on our website (www.smith-nephew.com)
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, so we can give back to our communities!
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.
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Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.
Explore our website and learn more about our mission, our team, and the opportunities we offer.
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