Medical Device QA Analyst

Job Title : Manual Tester – Medical Device Testing

Location : Gurugram

Experience : 3 to 7 Years

Employment Type : Full-Time

Job 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 :

Preferred Qualifications :