Medical Device Software QA Engineer — Cloud & Process

OrganOx; Oxford; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Healthcare

Retirement plans

Professional development

Job summary

OrganOx is seeking a Software Engineer, Quality & Process, to ensure our cloud platform and embedded medical devices meet stringent quality and regulatory standards. The role collaborates with Software, Quality and Regulatory teams to define processes, templates and documentation.

You will drive risk management, cybersecurity activities, and CI/CD improvements, ensuring compliance with ISO 13485, FDA regulations and IEC/I C 62304. This on-site Oxford position offers flexibility.

Qualifications

• Bachelor's degree in computer science, engineering, or a related field.
• Relevant certifications in software quality assurance or testing (e.g., ISTQB).
• Experience applying regulatory standards for Medical Devices (ISO 13485, FDA, EN 62304, IEC 62366).

Responsibilities

• Develop, implement and maintain the Software Technical File for products and define the documental strategy.
• Interface between Software, Quality and Regulatory teams.
• Define and execute improvements (CAPAs) and oversee SOUP and tool validations.

Skills

Software QA

Cloud solutions

CI/CD

Python/Java/C#

Communication

Education

BSc/BEng in CS/Eng

Tools

CI/CD tooling

Cloud platforms

Regulatory standards

Job description

OrganOx is seeking a Software Engineer, Quality & Process, to ensure our cloud platform and embedded medical devices meet stringent quality and regulatory standards. The role collaborates with Software, Quality and Regulatory teams to define processes, templates and documentation.

You will drive risk management, cybersecurity activities, and CI/CD improvements, ensuring compliance with ISO 13485, FDA regulations and IEC/I C 62304. This on-site Oxford position offers flexibility.