Medical Device Software QA Engineer: Cloud & Process

OrganOx, Inc.; Oxford; On-site; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Healthcare

Retirement plans

Job summary

OrganOx is seeking a Software Engineer, Quality & Process to ensure cloud platforms and embedded medical devices meet regulatory and quality standards. This role interfaces with Software, Quality and Regulatory teams and sits within the Software Development group, with a strong emphasis on risk management, documentation and SDLC best practices.

The position is on-site in Oxford with some flexibility, offering a path to impact OrganOx’s digital offerings and patient outcomes through robust QA,

Qualifications

• Experience in software QA for medical devices.
• Familiarity with cloud-based medical applications.
• Knowledge of ISO 13485, FDA, EN 62304.
• Experience with software lifecycle and testing.
• Cybersecurity risk management experience.
• Strong problem-solving skills.
• Excellent communicator and collaborator.
• CI/CD tooling experience in cloud environments.
• Knowledge of common cybersecurity standards.

Responsibilities

• Develop, implement and maintain the Software Technical File and QA documentation.
• Act as interface between Software, Quality and Regulatory teams.
• Define software processes to meet regulatory requirements (SOPs/WIs).
• Lead CAPA activities and risk management.
• Oversee SOUP and tool validations within QMS.

Skills

Medical device QA

Cloud software QA

Regulatory standards

Software development

Cybersecurity risk mgmt

Problem solving

Communication & collaboration

Cloud platforms (AWS/Azure/Google)

Diverse programming languages (Python/

Education

BSc in CS/Engineering

ISTQB certification

Tools

CI/CD pipelines

AWS

Azure

Google Cloud

Job description

OrganOx is seeking a Software Engineer, Quality & Process to ensure cloud platforms and embedded medical devices meet regulatory and quality standards. This role interfaces with Software, Quality and Regulatory teams and sits within the Software Development group, with a strong emphasis on risk management, documentation and SDLC best practices.

The position is on-site in Oxford with some flexibility, offering a path to impact OrganOx’s digital offerings and patient outcomes through robust QA,