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.