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Software Quality Assurance Specialist

2 months ago

Oxford, Oxfordshire, United Kingdom BioTalent Full time

Job Summary:

BioTalent is seeking a highly skilled Software Quality Assurance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the software meets all relevant regulatory requirements.

Key Responsibilities:

  • Regulatory Compliance: Ensure that software development and testing processes adhere to regulatory standards, including ISO 13485, ISO 60601, and IEC.
  • Documentation and Risk Management: Collaborate with partners to prepare and maintain detailed documentation, including test plans, test cases, test scripts, and test reports. Lead the identification, assessment, and mitigation of software-related and cybersecurity risks.
  • Risk Assessment and Mitigation: Develop and maintain a risk management plan in accordance with relevant standards and frameworks, ensuring all identified risks are documented and mitigated effectively.
  • Continuous Improvement: Regularly review and update risk assessments to address any emerging risks during the software development lifecycle.

Requirements:

  • 3+ years of experience in SaMD with a strong knowledge of ISO 13485, ISO 60601, and IEC.
  • Strong understanding of software development and testing processes.
  • Excellent communication and collaboration skills.