Medical Device Software QA Engineer – Cloud & Regulatory

OrganOx Limited; Town of Oxford; On-site; CAD 90,000 - 120,000; Full time

Benefits offered by this job

Healthcare

Retirement plans

Professional development opportunities

Job summary

OrganOx Limited is seeking a Software Engineer, Quality & Process to apply extensive software quality assurance experience to cloud solutions used in medical devices. This role ensures the cloud platform and devices meet regulatory standards and quality requirements.

Working within the Software Development team and in partnership with the QA function, you will develop and maintain software documentation, risk analyses (FMEA), and testing strategies, contributing to the regulation-compliant

Qualifications

• Bachelor’s degree in CS, engineering, or related field.
• ISTQB or similar software QA certification.
• Experience in medical device software lifecycle and regulatory standards.
• Experience with cloud platforms (AWS/Azure/GC) and IoMT.
• Strong QA, testing, and regulatory compliance knowledge.

Responsibilities

• Develop, implement and maintain Software Technical File.
• Interface between Software, Quality and Regulatory teams.
• Define software processes meeting regulatory requirements (SOPs/WIs).
• Drive software risk analysis and FMEA updates.
• Lead cybersecurity activities and risk mitigation.
• Collaborate with devs and PMs on testing strategies.

Skills

QA for medical devices

Cloud platforms

Regulatory standards

CI/CD pipelines

Risk management

Cybersecurity basics

Testing methodologies

Programming basics

Cross-functional teamwork

IoMT experience

Education

Bachelor’s degree in CS/engineering

ISTQB certification

Tools

CI/CD tooling

Job description

OrganOx Limited is seeking a Software Engineer, Quality & Process to apply extensive software quality assurance experience to cloud solutions used in medical devices. This role ensures the cloud platform and devices meet regulatory standards and quality requirements.

Working within the Software Development team and in partnership with the QA function, you will develop and maintain software documentation, risk analyses (FMEA), and testing strategies, contributing to the regulation-compliant