Senior QA Engineer - Medical Device Software

ZipRecruiter; London; On-site; GBP 50,000 - 80,000; Full time

Job summary

A leading neurotechnology start-up in London is seeking a Senior QA/RA Engineer to ensure software quality and regulatory compliance for medical devices. This role offers the opportunity to work on cutting-edge technologies aimed at improving brain disorder treatments. The position includes a competitive salary and excellent benefits, including company equity and unlimited holiday allowance.

Benefits

Company equity plan

Company pension scheme

Private medical, dental and vision insurance

Group life assurance

Comprehensive mental health support

Unlimited holiday allowance

Weekly lunches

Breakfast and snacks provided

Qualifications

• Demonstrable experience in QA/RA for software in medical devices.
• Strong knowledge of relevant regulations and standards.
• Hands-on experience with document control systems and CAPA management.

Responsibilities

• Develop and maintain software quality assurance processes in compliance with industry standards.
• Lead software validation and verification activities.
• Support regulatory submissions and ensure compliance.

Skills

ISO 13485

IEC 62304

FDA 21 CFR Part 820

EU MDR

Software validation

Risk management

Cybersecurity standards

Analytical skills

Problem-solving skills

Communication skills

Job description

Job Description

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.