Senior QA Engineer - Medical Device Software

JR United Kingdom; London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading neurotechnology start-up in London is seeking a Senior QA Engineer to ensure their medical software meets high quality and regulatory standards. The role involves developing QA processes, leading validation activities, and collaborating with engineers to enhance brain monitoring technology. This position offers a chance to impact lives through innovative solutions in medical devices.

Benefits

Excellent benefits

Qualifications

• Experience in QA/RA for medical device software or related fields.
• Strong knowledge of relevant regulations and standards.

Responsibilities

• Develop and maintain software QA processes compliant with ISO standards.
• Lead software validation and verification activities.

Skills

QA/RA

ISO 13485

IEC 62304

FDA 21 CFR Part 820

EU MDR

Risk Management

Analytical Skills

Communication

Tools

eQMS

Job description

Social network you want to login/join with:

Senior QA Engineer - Medical Device Software, London

Client: CT19

Location: London, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views: 4

Posted: 16.05.2025

Expiry Date: 30.06.2025

Job Description:

We have a 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 non-invasive neuromonitoring technology that aims to revolutionize clinical brain monitoring. Joining us, you will help create cutting-edge solutions to improve diagnosis and treatment of brain disorders, ultimately saving lives worldwide.

The Role

We are seeking a Senior QA/RA Engineer focused on software quality assurance and regulatory compliance for medical devices. You will ensure our medical technology software meets the highest quality and regulatory standards.

Location & Salary

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

Salary: Dependent on experience + excellent 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 considerations.
• 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, EU MDR regulations.
• Experience with software validation, V&V testing, and risk management (ISO 14971).
• Familiarity with 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 audits.
• Strong analytical, problem-solving, and detail-oriented skills.
• Excellent communication skills, translating regulatory requirements into engineering processes.