Job Description
About Us
For over 60 years, Vitalograph has been at the forefront of respiratory diagnostics, developing cutting-edge medical devices and software used worldwide. With operations in the UK, Ireland, Germany, and the USA, we’re committed to making a real difference in healthcare and clinical research.
Are you a Quality professional who thrives in a regulated environment and wants to make a real impact in medical devices? We’re looking for a
Quality Manager to play a key role in supporting and strengthening our UK medical device sales, service, and distribution operations.
This is a fantastic opportunity to work at the heart of a global medical device organisation, partnering closely with cross-functional teams and helping to ensure our Quality Management System continues to meet the highest standards.
Here’s What You Can Look Forward To
- Generous Time Off – 23 days of annual leave to recharge and unwind
- Financial Security – Excellent company contributed pension & 4x salary death-in-service benefit
- Comprehensive Healthcare – Company contributed private medical insurance for your well-being
- Ongoing learning support
What You’ll Be Doing
As Quality Manager, you’ll take ownership of Quality activities supporting our UK medical device sales, service, and distribution function, while working closely with the QA & Compliance Manager and wider Quality team.
Your Responsibilities Will Include
- 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
Qualifications (desirable)
What we’re looking for:
- Certification in Healthcare Quality Assurance or Quality Management
- ISO 9001 Lead or Internal Auditor certification
Experience & Skills
- 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
Why join Vitalograph?
You’ll be joining a respected, innovative medical device company where Quality truly matters. This role offers real ownership, exposure to global Quality systems, and the chance to influence processes that directly support patient care and business performance.