Software Quality Assurance Specialist

1 week ago

Oxford, Oxfordshire, United Kingdom OrganOx Full time
About the Role

OrganOx is 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). As a key member of our team, you will play a critical role in ensuring our cloud platform meets the stringent quality and regulatory standards required for medical devices.

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, including those associated with outsourced development and testing processes.
    • Develop and maintain a risk management plan in accordance with relevant standards and frameworks.
    • Regularly review and update risk assessments to address emerging risks during the software development lifecycle.
  • 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
  • Essential:
    • 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:
    • 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)

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