Manual Tester – Medical Device Testing
5 days ago
Job Title: Manual Tester – Medical Device TestingLocation: GurugramExperience: 3 to 7 YearsEmployment Type: Full-TimeJob Description:We are seeking a skilled and detail-oriented Manual Tester with experience in Medical Device Testing to join our team in Gurugram. The ideal candidate will have a strong background in manual testing methodologies, regulatory compliance (such as IEC 62304), and a passion for ensuring the safety and reliability of medical devices.Key Responsibilities:- Design, develop, and execute manual test cases based on software requirements and specifications.- Perform functional, regression, integration, and system testing on embedded medical devices and related software.- Document and track defects using tools like JIRA or Bugzilla.- Collaborate with cross-functional teams including developers, product managers, and regulatory teams.- Ensure compliance with medical device standards such as IEC 62304, ISO 14971, and FDA guidelines.- Participate in risk analysis, traceability matrix creation, and test documentation.- Support verification and validation (V&V) activities for software releases.Required Skills:- 3–7 years of experience in manual testing, preferably in the medical device domain.- Strong understanding of SDLC, STLC, and defect life cycle.- Experience with test management tools (e.g., HP ALM, TestRail).- Familiarity with regulatory standards like IEC 62304, ISO 13485, and FDA 21 CFR Part 11.- Good analytical and problem-solving skills.- Excellent communication and documentation skills.Preferred Qualifications:- Experience in embedded systems or firmware testing.- Knowledge of automation tools (e.g., Selenium, Robot Framework) is a plus.- ISTQB certification or equivalent is an advantage.
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