Quality Systems Manager

Entrepreneur First; City of London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading medical technology firm in London is seeking a Quality System Manager to take ownership of their Quality Management System. This role requires compliance with international medical device regulations, including ISO 13485:2016 and EU MDR 2017/745. The ideal candidate will have over 5 years of experience in quality leadership, with skills in risk management and documentation control. The position requires 4 days a week in the office and offers various benefits including a company equity plan and unlimited holiday allowance.

Benefits

Company equity plan

Company pension scheme

Private medical, dental and vision insurance

Group life insurance

Comprehensive mental health support

Unlimited holiday allowance

Weekly lunches

Breakfast and snacks provided

Qualifications

• 5+ years’ experience in medical device quality or QMS leadership.
• Deep knowledge of ISO 13485:2016, 21 CFR Part 820, and EU MDR 2017/745.
• Demonstrated success preparing for and managing audits.
• Strong working knowledge of risk management and CAPA.
• Excellent written and verbal communication skills.

Responsibilities

• Champion the Quality Management System and maintain compliance.
• Establish and maintain high-quality documentation processes.
• Lead the management review process with clear metrics.
• Plan and execute internal and external audit programmes.
• Oversee CAPA and nonconformance activities.
• Support supplier qualification and performance management.
• Maintain and develop the Quality Training Programme.
• Promote a culture of quality across the business.

Skills

Medical device quality leadership

ISO 13485:2016 compliance

Regulatory inspections management

Risk management (ISO 14971)

Documentation control systems

Written and verbal communication

Collaborative relationship building

Job description

Location

London, UK

Employment Type

Full time

Department

Engineering

At CoMind, we are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. In joining us, you will be helping to create cutting-edge technologies that will improve how we diagnose and treat brain disorders, ultimately improving and saving the lives of patients across the world.

The Role

We are seeking a Quality System Manager to take full ownership of our Quality Management System and eQMS and ensure compliance with international medical device regulations, including ISO 13485:2016, 21 CFR Part 820, and the EU MDR 2017/745.

This is a key role in ensuring that CoMind products and processes fully comply with the standards and regulations for medical devices, and maintain a rigorous focus on customer needs and expectations.

Please note this role requires 4 days per week in our Kings Cross office.

Responsibilities:

• Champion and continuously improve our Quality Management System (Qualio), maintaining compliance with ISO 13485:2016, 21 CFR Part 820, and EU MDR 2017/745.
• Establish and maintain high-quality documentation through robust document, record, and change control processes.
• Shape and evolve SOPs, Work Instructions, and business processes to align with the latest regulatory expectations and operational best practice.
• Lead the management review process, delivering clear quality metrics, insightful data analysis, and well-grounded improvement proposals.
• Plan, manage, and execute well-structured internal and external audit programmes.
• Oversee CAPA and nonconformance activities, driving strong root-cause investigations, risk assessments, and timely, effective resolutions.
• Support supplier qualification and performance management, working closely with Supplier Quality to maintain high external standards.
• Ensure partners, including CMOs, uphold CoMind’s quality requirements and operational excellence.
• Maintain and develop the Quality Training Programme, ensuring all staff are appropriately trained and up to date.
• Actively promote a culture of quality, compliance, and thoughtful continuous improvement across the business.

Skills & Experience:

• 5+ years’ experience in medical device quality or QMS leadership.
• Deep knowledge of ISO 13485:2016, 21 CFR Part 820 (FDA QSR), and EU MDR 2017/745.
• Demonstrated success preparing for and managing audits and regulatory inspections.
• Strong working knowledge of risk management (ISO 14971), CAPA, and documentation control systems.
• Excellent written and verbal communication skills, with the ability to build strong, collaborative relationships across teams.

Benefits:

• Company equity plan
• Company pension scheme
• Private medical, dental and vision insurance
• Group life insurance
• Comprehensive mental health support and resources
• Unlimited holiday allowance (+ bank holidays)
• Weekly lunches
• Breakfast and snacks provided.