QA Tester - Medical Devices Testing

Responsibilities: 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. Ensure that software testing QMS and compliance documentation meets regulatory requirements, including test plans, test cases, test reports, and defect tracking. Create detailed test plans based on software requirements, design specifications, and regulatory guidelines. Define testing scope, objectives, and strategies. Develop comprehensive test cases and scenarios to validate software functionality, performance, and compliance with regulatory standards. Execute manual and automated tests to verify software functionality, performance, and reliability. This includes functional testing, integration testing, system testing, and user acceptance testing. Ensure that software functions correctly in various scenarios and adheres to regulatory requirements for medical diagnostic devices. Identify, document, and track software defects and issues. Collaborate with development teams to resolve defects and retest as necessary. 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. Requirements: Bachelor's degree in computer science, Engineering, Life Sciences, or a related field. dvanced degrees or certifications (e.g., ISTQB, CSTE) are a plus. 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. Proficiency in test automation tools, programming languages, and software testing methodologies. Familiarity with medical device software development and testing standards. Strong analytical and problem-solving skills with a keen attention to detail to identify and address software issues. Excellent verbal and written communication skills to effectively interact with development teams, regulatory bodies, and stakeholders. In-depth knowledge of regulatory standards and guidelines relevant to medical device software, including risk management and compliance requirements.