- Senior
- Office in London
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 role is mission-critical in ensuring that CoMind and the entire product portfolio are ISO 13485 compliant. Please note this role requires 4 days per week in our Kings Cross office.
Responsibilities:
Champion and continuously refine our Quality Management System (Qualio), ensuring seamless compliance with ISO 13485:2016, 21 CFR Part 820, and EU MDR 2017/745
Safeguard high-quality documentation through robust document, record, and change control processes
Shape and evolve SOPs, Work Instructions, and Quality Manuals 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.
