Role: 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.
Responsibilities:
1. Regulatory Compliance and Standards Adherence:
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.
2. 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.
3. 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.
4. Defect Identification and Management:
o Detect Defects: Identify, document, and track software defects and issues. Collaborate with development teams to resolve defects and retest as necessary.
o Manage Defects: Use defect tracking tools to manage the lifecycle of identified issues, ensuring that they are addressed in a timely manner.
5. Documentation and Reporting:
6. Risk Management:
7. Collaboration and Communication:
8. Continuous Improvement:
9. Validation and Verification (V&V):
10. Training and Development:
Skills and Qualifications: • Educational Background: Bachelor's degree in computer science, Engineering, Life Sciences, or a related field. Advanced degrees or certifications (e.g., ISTQB, CSTE) are a plus. • Experience: 8-10 in medical device and life sciences software QMS testing, particularly in the medical device or diagnostic industry, with a strong understanding of regulatory requirements and quality standards. • Technical Skills: Proficiency in test automation tools, programming languages, and software testing methodologies. Familiarity with medical device software development and testing standards. • Attention to Detail: Strong analytical and problem-solving skills with a keen attention to detail to identify and address software issues. • Communication Skills: Excellent verbal and written communication skills to effectively interact with development teams, regulatory bodies, and stakeholders. • Regulatory Knowledge: In-depth knowledge of regulatory standards and guidelines relevant to medical device software, including risk management and compliance requirements.