SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
CoMind is developing non-invasive neuromonitoring technology to advance clinical brain monitoring and improve diagnosis and treatment of brain disorders.
As Director of Quality Assurance, you will lead the Quality function across three core areas: quality management system (QMS), design quality assurance (including software QA), and supplier quality assurance with QC activities. As the company approaches market release, you will prepare the QMS for customer-facing activities including post-market surveillance and complaint handling.
This is a player-coach role combining hands-on leadership with individual contribution. You will set direction and develop the team while also writing procedures, making decisions, and staying close to product and organizational needs. You will partner directly with engineering teams and collaborate closely with Regulatory Affairs leadership (regulatory is not part of this role).
Key responsibilities include:
- Leading and developing the existing Quality team with a focus on high performance culture
- Ensuring QMS compliance with FDA QMSR (21 CFR Part 820, harmonized with ISO 13485) and 21 CFR Part 11 for electronic records
- Leading annual ISO 13485 certification audits, FDA inspection readiness, and internal/supplier/customer audit programs
- Overseeing design controls, design transfer to manufacturing, DHFs/DHRs, ISO 14971 risk management, IEC 62366 usability, UDI requirements, and QA for integrated products spanning electronics, optics, and software
- Providing oversight on software development processes including IEC 62304, SaMD classification, and FDA SaMD/AI-ML guidance
- Providing oversight on cybersecurity aspects impacting product and business, including FDA premarket cybersecurity guidance (Section 524B)
- Leading supplier qualification, supplier audits, and manufacturing quality as the company builds toward commercial production
- Creating post-market QMS components from the ground up including complaint handling, product analytics, and on-market quality processes
- Working with Regulatory Affairs to compile Periodic Safety Update Reports, vigilance/MDR reporting, and field corrective actions/recalls
- Providing oversight on clinical evaluation and clinical data quality
All team members work at least 4 days per week from the Kings Cross offices with one flexible work-from-home day.
Requirements:
- Extensive leadership experience in Quality Assurance within ISO 13485 environments including product design, manufacturing, and commercial customer-facing operations
- Strong track record of building and managing high-performing Quality teams
- Expert command of core Quality toolkit: QMS, ISO 13485, design controls, ISO 14971 risk management, CAPA, validation, and supplier quality
- Experience hosting and leading audits, including annual certification audits (preferred: ASQ CQE/CQA/CMQ-OE, RAC, or Lead Auditor certification)
- Background in medical devices, ideally complex or integrated products (strong candidates from diagnostics, IVD, or pharma also 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 comfortable writing SOPs and making decisions independently
- Demonstrated ability to stay and build, motivated by the journey and shaping a function
