Senior QA Engineer - Medical Device Software (London Area)

New 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. 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 Senior QA/RA Engineer with a strong focus on software quality

assurance and regulatory compliance for medical devices. You will play a crucial role

in ensuring the software in our medical technology meets the highest quality and

regulatory standards.

QARA Software Specialist

Location: London (on-site 4 days a week)

Salary: Dependant on experience + Excellent benefits

Responsibilities

• Develop, implement, and maintain software quality assurance (QA) processes in compliance with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR.
• Lead software validation and verification (V&V) activities, including test planning, execution, and documentation.
• Collaborate with software engineers to ensure software development lifecycle (SDLC) compliance, including risk management (ISO 14971) and cybersecurity considerations.
• Support regulatory submissions (e.g., FDA 510(k), CE marking) by preparing software-related documentation such as Software Development Plans, Software Design History Files (DHF), and Software Bill of Materials (SBOM).
• Ensure that non-conformances, CAPAs, and audits related to software are effectively addressed and documented.

Skills & Experience

• Demonstrable experience in QA/RA for software in medical devices or a related field
• Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software
• Experience with software validation, V&V testing, and risk management (ISO 14971)
• Familiarity with software configuration management, cybersecurity standards, and AI/ML regulatory considerations is a plus
• Hands-on experience with document control systems (e.g., eQMS), CAPA management, and audit processes
• Strong analytical and problem-solving skills with a detail-oriented mindset
• Excellent communication skills, with the ability to translate regulatory requirements into practical engineering processes.

Benefits:

• Company equity plan
• Company pension scheme
• Private medical, dental and vision insurance
• Group life assurance
• Comprehensive mental health support and resources
• Unlimited holiday allowance (+ bank holidays)
• Weekly lunches
• Breakfast and snacks provided.