Job Description

• QA Software Tester for Medical Diagnostic Devices.

• In this role, the QA Software Tester ensures that software for medical diagnostic devices is rigorously tested, compliant with regulatory standards, and meets high quality and safety standards.

• This role is essential for maintaining the reliability and efficacy of diagnostic devices in clinical settings.

• Relevant medical device regulations 8-10 years' experience and expertise (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304) working in agile environment to ensure software testing practices comply with these standards and Organizational QMS standards.

• Document Compliance: Ensure that software testing QMS and compliance documentation meets regulatory requirements, including test plans, test cases, test reports, and defect tracking.

• Test Planning and Design.

• Develop Test Plans: Create detailed test plans based on software requirements, design specifications, and regulatory guidelines. Define testing scope, objectives, and strategies.

• Design Test Cases: Develop comprehensive test cases and scenarios to validate software functionality, performance, and compliance with regulatory standards.

• Execution and Verification.

• Perform Testing: Execute manual and automated tests to verify software functionality, performance, and reliability. This includes functional testing, integration testing, system testing, and user acceptance testing.

• Verify Compliance: Ensure that software functions correctly in various scenarios and adheres to regulatory requirements for medical diagnostic devices.

• Defect Identification and Management

• Detect Defects: Identify, document, and track software defects and issues. Collaborate with development teams to resolve defects and retest as necessary.

• Manage Defects: Use defect tracking tools to manage the lifecycle of identified issues, ensuring that they are addressed in a timely manner.

• Documentation and Reporting.

• Risk Management

• Collaboration and Communication.

• Continuous Improvement.

• Validation and Verification (V&V).

• Training and Development.

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