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- Tasks: Lead and improve the Quality Management System for medical devices.
- Company: Smith+Nephew, a leader in innovative medical technology.
- Benefits: Generous bonuses, flexible work, health plans, and employee discounts.
- Why this job: Make a real impact on patient safety and product quality.
- Qualifications: Degree in Engineering or Life Sciences and 3 years in Quality Assurance.
- Other info: Join a community committed to inclusion and continuous improvement.
The predicted salary is between 48000 - 72000 £ per year.
Overview Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. We are currently searching for a Senior QMS Manager to establish, maintain, and continuously improve the Quality Management System (QMS) in compliance with applicable medical device regulations and standards. This role ensures that products remain safe, effective, and compliant throughout their entire lifecycle. The Senior QMS Manager will lead and manage operational quality systems, including CAPA, deviation management, and controlled document systems, while coaching and developing the team to drive continuous improvement in business outcomes, individual performance, and overall team effectiveness.
Responsibilities
- Own and continuously evolve the Site Quality Management System in alignment with ISO 13485, FDA 21 CFR Part 820, EU MDD/MDR, and applicable global regulatory requirements.
- Monitor changes in global regulatory requirements and assess impact on the QMS.
- Ensure quality management system processes for the site are compliant and efficient (including NC/CAPA, Management Review, Change Control, DMR, Document Control and Archive).
- Lead regulatory inspection readiness, inspection management and response activities.
- Support the internal and/or external audit programme by contributing to audits, in co-operation with the audit team to ensure site wide compliance with relevant procedures.
- Ensure systemic resolution of internal and external audit findings and prevention of recurrence.
- Provide executive oversight of the CAPA system, ensuring robust root cause analysis and effectiveness verification.
- Ensure data-driven decision-making using quality metrics and KPIs.
- Operate the Management Review process, including administrative and action completion activities.
- Manage escalation and local site tracking of Health Hazard Evaluations / Preliminary Risk Assessments / Quality Holds.
Requirements / Qualifications
- Degree educated in Engineering, Life Sciences, or a related discipline.
- Minimum of 3 years' experience working in Quality Assurance within the Medical Device and/or Pharmaceutical industry.
- Proven hands-on experience in medical device quality management systems.
- Strong working knowledge of relevant regulations and standards, including ISO 13485, FDA 21 CFR Part 820, QSR/QMSR, and EU MDD/MDR.
Preferred Qualifications
- Quality or regulatory certifications (e.g., ISO Lead Auditor).
- Lean Six Sigma certification (Green Belt or Black Belt).
- Demonstrated leadership capability with strong cross-functional communication skills.
Senior QMS Manager employer: Smith+Nephew
Contact Detail:
Smith+Nephew Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QMS Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a Senior QMS Manager role or can refer you directly.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and FDA regulations. Be ready to discuss how you've successfully managed quality systems in the past, and don’t forget to highlight your leadership skills!
✨Tip Number 3
Showcase your continuous improvement mindset! During interviews, share specific examples of how you've driven improvements in quality management systems. This will demonstrate your proactive approach and alignment with the company's goals.
✨Tip Number 4
Don’t just apply anywhere; apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows your genuine interest in being part of the Smith+Nephew community.
We think you need these skills to ace Senior QMS Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior QMS Manager role. Highlight your experience with quality management systems and relevant regulations like ISO 13485 and FDA standards. We want to see how your background aligns 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 continuous improvement in past roles, as this will resonate with us.
Showcase Your Leadership Skills: As a Senior QMS Manager, you'll be leading a team. Make sure to highlight your leadership experience and how you've coached others to achieve their best. We love seeing candidates who can inspire and develop their teams!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you can explore more about our culture and values while you're there!
How to prepare for a job interview at Smith+Nephew
✨Know Your Regulations
Make sure you brush up on ISO 13485, FDA 21 CFR Part 820, and EU MDD/MDR before the interview. Being able to discuss how these regulations impact quality management systems will show that you’re not just familiar with them, but that you can apply this knowledge practically.
✨Showcase Your Leadership Skills
Prepare examples of how you've led teams or projects in the past, especially in relation to CAPA and deviation management. Highlighting your ability to coach and develop others will resonate well with the interviewers, as they’re looking for someone who can drive continuous improvement.
✨Be Data-Driven
Come ready to discuss how you’ve used quality metrics and KPIs to make decisions in previous roles. This will demonstrate your analytical skills and your commitment to data-driven decision-making, which is crucial for the Senior QMS Manager position.
✨Prepare for Scenario Questions
Expect to be asked about specific situations you’ve faced in quality assurance. Think of a few challenging scenarios where you had to ensure compliance or resolve audit findings, and be ready to explain your thought process and the outcomes.
