Quality Manager

Recruiting for a Quality Manager to play a key role in supporting and strengthening our UK medical device sales, service, and distribution.

• Managing and supporting the UK Quality Management System (QMS) for medical device sales, service, and distribution
• Providing Quality Assurance input into UK QMS processes and business activities
• Supporting supplier qualification activities for both Vitalograph Ltd and Vitalograph Inc
• Assisting with internal audits and supporting external audit readiness
• Acting as the UK Quality representative for medical device sales, service, and distribution activities
• Supporting oversight and maintenance of UK ISO 9001 certification
• Monitoring changes in legislation, standards, and best practice within medical device Quality and regulatory environments, and taking appropriate action
• Supporting Quality metrics generation, analysis, and reporting to drive continuous improvement
• Overseeing the implementation of new or revised QA procedures
• Supporting investigations, Issue Reports, and related CAPAs
• Preparing and delivering Quality and compliance training where required
• Reviewing, updating, and controlling SOPs, work instructions, and controlled documentation
• Coordinating responses to customer, audit, and IT quality questionnaires
• Maintaining a database of approved responses for Quality and information requests
• Supporting wider Quality and Compliance initiatives as required

• Minimum of 3 years’ experience in Quality Management roles within pharma or medical devices
• Strong working knowledge of ISO 9001 and FDA medical device Quality requirements, ideally within respiratory or diagnostic solutions
• Experience conducting internal audits and supporting or hosting external audits
• Strong organisational skills with the ability to manage multiple priorities
• Excellent attention to detail and a structured, methodical approach
• Confident communicator with strong written and verbal skills
• Solid administrative capability and high level of computer literacy (MS Word, Excel, PowerPoint)
• Demonstrated leadership skills; previous line management experience is an advantage
• Certification in Healthcare Quality Assurance or Quality Management
• ISO 9001 Lead or Internal Auditor certification

Vitalograph Ltd, Vitalograph Business Park,, Maids Moreton, BUCKINGHAM, MK18 1SW