Senior QMS Manager

Smith & Nephew; Hull and East Yorkshire; Hybrid; GBP 60,000 - GBP 80,000; Full time

Job summary

A leading medical technology company in the UK is seeking a Senior QMS Manager to establish and maintain the Quality Management System in compliance with medical device regulations. The role involves leading operational quality systems, ensuring compliance, and driving continuous improvement within the team. Candidates should have a degree in Engineering or Life Sciences and at least 3 years of experience in Quality Assurance. This position offers a competitive salary and flexible working arrangements.

Benefits

Generous annual bonus

Flexible vacation and time off

Private health and dental plans

Discounts on gyms and fitness clubs

Training and mentorship programs

Qualifications

• 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.

Responsibilities

• Establish and maintain the Quality Management System (QMS).
• Lead and manage operational quality systems including CAPA and deviation management.
• Ensure systemic resolution of internal and external audit findings.

Skills

Quality Management Systems

Regulatory Compliance

Team Leadership

Root Cause Analysis

Education

Degree in Engineering or Life Sciences

Tools

ISO 13485

FDA 21 CFR Part 820

Job description

Senior QMS Manager page is loaded## Senior QMS Managerlocations: UK - Hull Manufacturingtime type: Full timeposted on: Posted Todayjob requisition id: R87429**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. 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.* 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* 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***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 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 discountsStay connected by joining our .We're more than just a company - we're a community! Follow us on to see how we support and empower our employees and patients every day. Check us out on for a glimpse behind the scenes and a sneak peek into **You. Unlimited.**, life, culture, and benefits at S+N.Explore our and learn more about our mission, our team, and the opportunities we offer.Stay connected by joining our .We're more than just a company - we're a community! Follow us on to see how we support and empower our employees and patients every day. Check us out on for a glimpse behind the scenes and a sneak peek into **You. Unlimited.**, life, culture, and benefits at S+N.Explore our and learn more about our mission, our team, and the opportunities we offer.Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential.From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.