QA Tester - Medical Devices Testing
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- 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.
- Educational Background: Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field. Advanced degrees or certifications (e.g., ISTQB, CSTE) are preferred.
- Experience:
- 8-10 years of experience in software testing, with a focus on medical devices or diagnostic systems.
- Strong experience with QMS software testing.
- Technical Skills:
- Proficiency in test automation tools, programming languages, and various software testing methodologies.
- Knowledge of medical device software development and testing standards.
- Attention to Detail:
- Strong analytical and problem-solving skills with the ability to detect and address software issues.
- Communication Skills:
- Excellent verbal and written communication skills for effective collaboration with development teams, regulatory bodies, and stakeholders.
- Regulatory Knowledge:
- Deep understanding of FDA 21 CFR Part 820, ISO 13485, and other medical device software regulations.
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