Senior QA Engineer - Medical Device Software

Senior QA Engineer – Medical Device Software

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. By joining us, you will help create cutting-edge technologies to improve diagnosis and treatment of brain disorders, ultimately saving lives worldwide.

The Role

We 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 Specialist

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

Salary: Dependent on experience + benefits

Responsibilities

• Develop, 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 & Experience

• Experience 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 Benefits

• Company equity plan
• Company pension scheme
• Private medical, dental, and vision insurance
• Group life assurance
• Mental health support
• Unlimited holiday (+ bank holidays)
• Weekly lunches, breakfast, and snacks

Additional Details

• Senior level: Mid-Senior
• Employment type: Full-time
• Job function: Engineering and Quality Assurance
• Industries: Medical Equipment Manufacturing, Biotechnology Research

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