Senior QMS Manager

Eagleston Financial Group; United Kingdom; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

A healthcare technology company in the United Kingdom seeks a Senior QMS Manager to manage and improve the Quality Management System in accordance with medical device regulations. Responsibilities include leading the QMS operations, ensuring compliance with global standards, and facilitating regulatory inspections. Candidates should hold a degree in Engineering or Life Sciences with a minimum of eight years in Quality Assurance within the medical device or pharmaceutical sectors. The role offers a hybrid working model and extra perks, including a generous bonus scheme.

Benefits

Generous annual bonus

Flexible vacation and time off

Private health and dental plans

Discounts on gyms and fitness clubs

Qualifications

• Minimum of eight years of experience in Quality Assurance in medical devices or pharmaceuticals.
• Hands-on experience in quality management systems.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDD/MDR.

Responsibilities

• Own and evolve the Site Quality Management System.
• Lead regulatory inspection readiness and audit support.
• Ensure compliance and efficiency of QMS processes.

Skills

Quality Assurance

Regulatory Compliance

Cross-Functional Communication

Root Cause Analysis

Education

Degree in Engineering or Life Sciences

Job description

Senior QMS Manager

Life. Unlimited. At Smith+Neg 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.

What will you be doing?

• 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 cooperation with the audit team to ensure site-wide compliance with relevant procedures.
• Ensure systemic resolution of internal and external audit findings and prevent 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.

What will you need to be successful?

• Degree educated in Engineering, Life Sciences, or a related discipline.
• Minimum of yey years of experience working in Quality Assurance within the Medical Device and/or Pharmaceutical industry.
• Proven hands‑on experience in medical device quality management وژل• (systems.schemas). (?) [removed]history .
• 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 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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