Quality Systems Manager

2 weeks ago

City Of London, United Kingdom CoMind Full time

Join to apply for the Quality Systems Manager role at CoMind 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. Note: this role requires four 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. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Quality Assurance Medical Equipment Manufacturing Location: London, England, United Kingdom #J-18808-Ljbffr

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