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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