What are the responsibilities and job description for the QA Tester - Medical Devices Testing position at Katalyst HealthCares and Life Sciences?
Responsibilities and Requirements :
- 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.
