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Director of Quality Assurance

CoMind· Product Development
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London, UK£120k - £140kFull-timePosted 4w ago

About the role

Director of Quality Assurance leading the Quality function across quality management system, design quality assurance (including software), and supplier quality assurance, with post-market activities and hands-on leadership in a medical devices environment.

Responsibilities

  • Lead and develop the existing Quality team, instilling a high-performance culture.
  • Ensure the QMS complies with FDA QMSR (21 CFR Part 820, harmonised with ISO 13485) and 21 CFR Part 11 for electronic records and signatures.
  • Lead annual ISO 13485 certification audit, FDA inspection readiness, and manage internal, supplier, and customer audit programmes.
  • Oversee design controls and design transfer to manufacturing including DHFs and DHRs, ISO 14971 risk management, IEC 62366 usability, UDI, and QA across electronics, optics, and software.
  • Provide oversight on software development processes including IEC 62304, SaMD classification, and FDA SaMD/AI-ML guidance.
  • Oversee cybersecurity aspects including FDA premarket cybersecurity guidance (Section 524B).
  • Lead supplier qualification, supplier audits, and manufacturing quality as we approach commercial production; establish processes for Device Master Records and batch record transfer.
  • Create the post-market side of the QMS with complaint handling, product analytics, and on-market quality processes.
  • Coordinate with Regulatory Affairs on PSUR, vigilance/MDR reporting, and field actions/recalls per EU MDR/FDA obligations.
  • Provide guidance on clinical evaluation / clinical data quality.

Qualifications

  • Extensive leadership experience in Quality Assurance within an ISO 13485 environment including product design, manufacturing and commercial customer-facing operations.
  • Strong track record of building and managing high-performing Quality teams.
  • Expert command of QMS, ISO 13485, design controls, ISO 14971 risk management, CAPA, validation, and supplier quality.
  • Experience hosting and leading audits, including annual certification audits; preferred audit certifications (ASQ CQE/CQA/CMQ-OE, RAC, Lead Auditor).
  • Background in medical devices, ideally complex or integrated products; candidates from diagnostics, IVD or pharma considered.
  • Experience in software-intensive / connected-devices.
  • Working knowledge of FDA/EU MDR and UK CA regulatory frameworks.
  • SaMD/software quality experience, human factors, or cybersecurity awareness.
  • Hands-on operator capable of writing SOPs and making decisions independently.
  • Proven ability to stay and build an evolving function.

Skills

Required:Quality Management System (QMS)Design ControlsRisk ManagementRegulatory Knowledge
Nice to have:Cybersecurity

Benefits

  • Company equity plan so all employees share in the success of the company
  • Salary-sacrifice pension scheme
  • Private medical, dental and vision insurance (medical history disregarded)
  • Group life assurance at 4x annual income
  • Comprehensive mental health support with unlimited 1:1 sessions
  • Unlimited holiday allowance (+ bank holidays) and one remote-working week per quarter
  • Lunch voucher (£10) and free dinner on late-workdays
  • Twice weekly fruit deliveries and snacks
  • YuLife subscription for wellness discounts
Last updated Sep 23, 2026. Interested? Apply on the company site.

About CoMind

The Future of Neurotechnology is Non-Invasive

Our mission is to redefine the way the brain is measured and treated to optimise patient outcomes across the care continuum.

NeurotechnologyMedical DevicesNon-Invasive
Company profileWebsite

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