Senior QMS Manager

Eagleston Financial Group; United Kingdom; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading financial services firm in the United Kingdom is seeking a Senior QMS Manager to establish and enhance the Quality Management System in accordance with medical device regulations. This role is responsible for ensuring product safety and compliance throughout the lifecycle. The ideal candidate will have expertise in ISO 13485 and FDA regulations, managing quality processes, and driving continuous improvement within the team.

Qualifications

• Expertise in ISO 13485 and FDA 21 CFR Part 820.
• Strong background in quality management system processes.

Responsibilities

• Own and evolve the Site Quality Management System.
• Monitor changes in global regulatory requirements.
• Ensure compliance and efficiency of quality management system processes.

Job description

Life. Unlimited. At Smith+ Ne pphew 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).