Quality Manager

Vitalograph Inc; United Kingdom; On-site; GBP 40,000 - GBP 60,000; Full time

Job summary

A global medical device organization is seeking a Quality Manager to oversee the UK Quality Management System for medical device sales. This role requires experience in Quality Management, strong knowledge of ISO 9001, and the ability to manage audits and compliance. The ideal candidate will possess excellent organizational and communication skills, and a minimum of three years’ experience in a related role. Join us to make a significant impact in the healthcare sector.

Benefits

Generous Time Off

Excellent company contributed pension

Comprehensive Healthcare

Ongoing learning support

Qualifications

• 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.
• Experience conducting internal audits and supporting or hosting external audits.

Responsibilities

• Managing and supporting the UK Quality Management System for medical device sales.
• Providing Quality Assurance input into UK QMS processes.
• Supporting supplier qualification activities for both Vitalograph Ltd and Vitalograph Inc.

Skills

Quality Management

ISO 9001

FDA requirements

Internal audits

Strong communication

Leadership skills

Organizational skills

Education

Certification in Healthcare Quality Assurance

ISO 9001 Lead Auditor Certification

Tools

MS Word

Excel

PowerPoint

Job description

About Us

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

• 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

What we’re looking for

Qualifications (desirable):

• 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.

Apply Now

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