8 дней назад
Director of Quality Assurance (Medical Devices)
120 000 - 140 000GBP
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director of Quality Assurance (Medical Devices): Leading the quality management system, design and software quality assurance, supplier quality, and post-market quality for non-invasive neuromonitoring technology with an accent on ISO 13485, FDA QMSR, medical-device design controls, and integrated electronics, optics, and software. Focus on preparing audits and commercial production, building post-market surveillance and complaint-handling processes, and guiding SaMD, cybersecurity, risk management, and supplier quality activities.
Location: London, UK; at least 4 days per week in the Kings Cross offices, plus 1 flexible work-from-home day
Salary: £120K–£140K per year, plus equity
Company
develops non-invasive neuromonitoring technology for clinical brain monitoring, diagnosis, and treatment of brain disorders.
What you will do
- Lead and develop the Quality team and maintain a high-performance culture.
- Own the quality management system, ensuring compliance with FDA QMSR, 21 CFR Part 11, and ISO 13485.
- Lead ISO 13485 certification audits, FDA inspection readiness, and internal, supplier, and customer audit programs.
- Oversee design controls, design transfer, DHFs, DHRs, ISO 14971 risk management, IEC 62366 usability, UDI requirements, and quality assurance across electronics, optics, and software.
- Guide software quality processes, SaMD classification, FDA AI/ML guidance, cybersecurity, and supplier and manufacturing quality.
- Build post-market quality processes, including complaint handling, product analytics, vigilance and MDR reporting, PSURs, and field corrective actions or recalls.
Requirements
- Extensive Quality Assurance leadership experience in an ISO 13485 environment across product design, manufacturing, and customer-facing operations.
- Expertise in QMS, ISO 13485, design controls, ISO 14971 risk management, CAPA, validation, and supplier quality.
- Experience leading certification and other audits; ASQ, RAC, or Lead Auditor certification is preferred.
- Background in medical devices, diagnostics, IVD, or pharma, including software-intensive or connected devices.
- Working knowledge of FDA, EU MDR, and UK CA regulatory frameworks, with experience in SaMD, human factors, or cybersecurity.
- Hands-on ability to write SOPs, make quality decisions, and build processes while working closely with engineering and Regulatory Affairs.
Culture & Benefits
- Player-coach role combining hands-on quality leadership with team development.
- Company equity plan.
- Salary-sacrifice pension, private medical, dental and vision insurance, and group life assurance at 4x annual income.
- Unlimited holiday allowance plus bank holidays, with one week of remote working per quarter.
- Mental health support, daily lunch vouchers, late-work dinners, fresh fruit, snacks, drinks, and a YuLife subscription.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →