Regulatory Compliance and Standards Adherence:

• Ensure software testing complies with relevant medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
• Maintain adherence to Organizational QMS standards.
• Prepare and maintain compliance documentation including test plans, test cases, test reports, and defect tracking logs.

Test Planning and Design:

• Develop detailed test plans based on software requirements and design specifications.
• Define testing objectives, scope, and strategies aligned with regulatory guidelines.
• Design comprehensive test cases to ensure software functionality, performance, and compliance with regulatory standards.

Execution and Verification:

• Execute both manual and automated tests to verify software functionality, performance, and reliability.
• Conduct functional testing, integration testing, system testing, and user acceptance testing to ensure system compliance.
• Ensure software functions adhere to regulatory standards in various clinical scenarios.

Defect Identification and Management:

• Identify, document, and track software defects and issues.
• Collaborate with development teams to resolve defects and retest as necessary.
• Manage defect tracking using appropriate tools to ensure timely resolution.

Documentation and Reporting:

• Prepare clear and detailed test reports and documentation for submission to relevant stakeholders.
• Ensure all testing documentation aligns with regulatory standards.

Risk Management:

• Participate in risk assessments and develop risk mitigation strategies for software testing.

Collaboration and Communication:

• Work closely with cross-functional teams including development, quality assurance, and regulatory teams to ensure project success.
• Effectively communicate test results and issues to stakeholders.

Continuous Improvement:

• Identify areas for improvement in testing processes and propose innovative solutions.
• Keep up to date with advances in test automation and medical device standards.

Validation and Verification (V&V):

• Lead validation and verification efforts, ensuring full adherence to medical device regulatory requirements.

Training and Development:

• Provide training to junior testers and ensure compliance with the best testing practices.