Senior QA Engineer - Medical Device SoftwareNew opportunity for a QARA Software Engineer with experience in Medical Devices to join one of London’s most exciting neurotechnology start-ups.We are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. By joining us, you will help create cutting-edge technologies to improve diagnosis and treatment of brain disorders, ultimately saving lives worldwide.The RoleWe seek a Senior QA/RA Engineer focused on software quality assurance and regulatory compliance for medical devices. You will ensure our medical software meets the highest quality and regulatory standards.QARA Software SpecialistLocation: London (on-site 4 days/week)Salary: Dependent on experience + benefitsResponsibilitiesDevelop, implement, and maintain software QA processes compliant with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR.Lead software validation and verification activities, including test planning, execution, and documentation.Collaborate with software engineers to ensure SDLC compliance, including risk management (ISO 14971) and cybersecurity.Support regulatory submissions by preparing documentation such as Software Development Plans, DHF, and SBOM.Address and document non-conformances, CAPAs, and audits related to software.Skills & ExperienceExperience in QA/RA for medical device software or related fields.Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations.Experience with software validation, V&V testing, and risk management (ISO 14971).Familiarity with configuration management, cybersecurity standards, and AI/ML regulations is a plus.Hands-on with document control systems (e.g., eQMS), CAPA, and audits.Analytical, detail-oriented, with excellent communication skills to translate regulatory requirements into engineering processes.Additional BenefitsCompany equity planCompany pension schemePrivate medical, dental, and vision insuranceGroup life assuranceMental health supportUnlimited holiday (+ bank holidays)Weekly lunches, breakfast, and snacksAdditional DetailsSenior level: Mid-SeniorEmployment type: Full-timeJob function: Engineering and Quality AssuranceIndustries: Medical Equipment Manufacturing, Biotechnology Research #J-18808-Ljbffr