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Software Quality Assurance Specialist

2 months ago

Oxford, Oxfordshire, United Kingdom OrganOx Full time
Job Summary

We are seeking a highly skilled Software Quality Assurance Specialist to join our team on a temporary 6-month contract and on a part-time basis (3 days per week) at OrganOx, a rapidly growing medical device company committed to developing innovative products that save lives.

Key Responsibilities
  • Quality Assurance & Testing:
    • Develop, implement, and maintain comprehensive test plans and test cases for our digital platform.
    • Oversee and review testing output, including functional, regression, performance, and security testing.
  • Compliance & Documentation:
    • Ensure the software meets all relevant regulatory requirements.
    • Prepare and maintain detailed documentation, including test plans, test cases, test scripts, and test reports.
  • Risk and Cybersecurity Risk Management:
    • Identify, assess, and mitigate software-related and cybersecurity risks.
    • Develop and maintain a risk management plan in accordance with relevant standards and frameworks.
  • Collaboration & Communication:
    • Work closely with software developers, product managers, and other stakeholders to understand requirements and design effective testing strategies.
    • Communicate findings, risks, and recommendations clearly and effectively to technical and non-technical stakeholders.
Requirements
  • Proven experience in software quality assurance, with a focus on cloud solutions.
  • Strong understanding of software testing methodologies, tools, and processes.
  • Familiarity with regulatory standards and compliance requirements for medical devices (e.g., ISO 13485, FDA regulations).
  • Experience overseeing and coordinating with outsourced development and testing teams.
  • Demonstrated experience in software risk management, including cybersecurity risk management.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and collaboration skills.
  • Qualification in Computer Science or Engineering.
Desirable Skills
  • Experience with cloud platforms such as AWS, Azure, or Google Cloud.
  • Knowledge of medical device software lifecycle processes.
  • Proficiency in programming languages such as Python, Java, or C#.
  • Experience with continuous integration/continuous deployment (CI/CD) pipelines.
  • Familiarity with relevant cybersecurity standards and frameworks (e.g., IEC 62443, NIST Cybersecurity Framework).
About OrganOx

We recruit and retain the best people from a broad range of diverse backgrounds who share our values of innovation, evidence, integrity, teamwork, respect, and passion. If you're looking for a challenging and rewarding role in a fast-paced and innovative environment, we want to hear from you.