Manual QA Engineer (Medical Devices)

Job Description Manual QA Engineer (Medical Devices) Location: Pune Experience: 35 Years About the Role We are looking for a detail-oriented Manual QA Engineer with experience in the Medical Devices domain to join our engineering team in Pune. The ideal candidate should have hands-on experience in manual software testing, a strong understanding of software quality assurance processes, and exposure to AI-powered testing tools or AI-enabled healthcare applications. Experience working in regulated environments and familiarity with medical standards is highly desirable. Key Responsibilities Design, develop, and execute manual test cases based on functional and system requirements. Validate software applications used in medical devices and healthcare solutions. Perform functional, regression, integration, system, and exploratory testing. Identify, document, track, and verify software defects using defect management tools. Collaborate with developers, business analysts, and product owners to understand requirements and ensure product quality. Participate in requirement reviews and provide inputs for testability and quality improvements. Support verification and validation (V&V) activities for medical device software. Ensure compliance with software development and quality processes in regulated environments. Utilize AI-powered testing tools (such as GitHub Copilot, ChatGPT, Microsoft Copilot, or similar AI assistants) to improve test case creation, documentation, defect analysis, and productivity. Contribute to continuous improvement of QA processes and testing methodologies. Required Skills 35 years of experience in Manual Software Testing. Experience testing Medical Device or Healthcare software applications. Strong knowledge of Software Testing Life Cycle (STLC) and Software Development Life Cycle (SDLC). Experience in writing test scenarios, test cases, and executing test plans. Good understanding of Functional, Regression, Integration, System, and User Acceptance Testing. Experience with defect tracking tools such as Jira or Azure DevOps. Basic understanding of SQL for database validation. Excellent analytical, debugging, and communication skills. Medical Domain Experience Experience with one or more of the following is preferred: Medical Device Software Testing DICOM HL7/FHIR PACS/RIS FDA regulations IEC 62304 ISO 13485 Verification & Validation (V&V) AI Skills (Preferred) Hands-on experience using AI-assisted development/testing tools such as GitHub Copilot, ChatGPT, Microsoft Copilot, or similar . Experience leveraging AI for: Test case generation Test data creation Requirement analysis Defect analysis Test documentation Understanding of AI/ML-enabled healthcare or medical device applications is an added advantage. Preferred Qualifications Bachelor''s degree in Computer Science, Electronics, Biomedical Engineering, or a related field. Experience working in Agile/Scrum environments. ISTQB Certification is a plus. Good to Have Exposure to basic automation testing concepts. Knowledge of API testing using Postman. Experience with risk-based testing in regulated environments. Familiarity with cloud-based healthcare applications. This role is ideal for a QA professional who combines strong manual testing expertise with medical device domain knowledge and an interest in using AI tools to improve software quality and testing efficiency.