At a Glance
- Tasks: Ensure our Quality Management System meets global medical device regulations and supports continuous improvement.
- Company: Join Smith+Nephew, a leader in innovative medical technology.
- Benefits: Generous bonuses, flexible vacation, health plans, and employee discounts.
- Other info: Enjoy a hybrid working model and 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.
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?
- 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.
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.
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.
Stay connected by joining our Talent Community. We're more than just a company - we're a community!
QMS Specialist employer: Smith & Nephew
At Smith+Nephew, we pride ourselves on being an exceptional employer, offering a dynamic work culture that prioritises inclusion and employee wellbeing. As a QMS Specialist in Hull, you will benefit from generous annual bonuses, flexible working arrangements, and comprehensive health plans, all while contributing to meaningful advancements in medical technology. Our commitment to continuous improvement and professional development ensures that you will have ample opportunities to grow your career in a supportive environment dedicated to making a positive impact on patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land QMS Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already at Smith+Nephew. A friendly chat can open doors and give you insights that might just set you apart from other candidates.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of ISO 13485 and FDA regulations. We want to see that you’re not just familiar with the terms but can also discuss how they apply in real-world scenarios.
✨Tip Number 3
Showcase your problem-solving skills! Be ready to share examples of how you've used data analysis and root cause methodologies to drive improvements in past roles. We love hearing about your hands-on experience!
✨Tip Number 4
Don’t forget to 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 being part of our community.
We think you need these skills to ace QMS Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the QMS Specialist role. Highlight your experience in Quality Assurance, especially with ISO 13485 and FDA regulations. 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 management in the medical device industry. Share specific examples of how you've driven improvements in past roles – we love a good story!
Showcase Your Analytical Skills:Since data analysis is key in this role, make sure to mention any relevant experience you have with identifying trends and applying root cause analysis. We’re keen to see how you can contribute to our continuous improvement efforts!
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll find all the details you need to submit your application. Let’s get started on this journey together!
How to prepare for a job interview at Smith & Nephew
✨Know Your QMS Inside Out
Make sure you have a solid grasp of Quality Management Systems, especially ISO 13485 and FDA regulations. Brush up on your knowledge of CAPA, document control, and audit management processes. Being able to discuss these topics confidently will show that you're ready to take on the role.
✨Prepare for Scenario Questions
Expect questions that ask how you've handled specific quality issues in the past. Think of examples where you identified trends or implemented improvements. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly and effectively.
✨Show Your Collaborative Spirit
Since this role involves working with cross-functional teams, be prepared to discuss how you've successfully collaborated with others in previous positions. Highlight your communication skills and give examples of how you've influenced or trained team members to enhance quality processes.
✨Demonstrate Continuous Improvement Mindset
Smith+Nephew values a focus on continuous improvement. Be ready to talk about how you've used data analysis and root cause methodologies to drive meaningful change in your previous roles. This will show that you align with their commitment to operational excellence.
