QA (10276)

Requisition ID 10276 - Posted

Job Description – Manual QA Engineer (Medical Devices)

Location: Pune
Experience: 3–5 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

• 3–5 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.