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Job Description
Structured overview of role & requirementsAbout This Role
Lead and manage validation activities for medical imaging study software ensuring compliance with SOPs, regulatory standards, and quality benchmarks.
Review, approve, and maintain Computer System Validation documentation and test materials, ensuring traceability and audit readiness.
Coordinate testing efforts including planning, defect management, environment setup, and status reporting across multiple projects and teams, including offshore coordination.
Minimum Requirements
Bachelor of Technology or equivalent in IT, Computer Science, Engineering, or related field.
5–10 years of experience in software testing, quality engineering, validation, or verification and validation.
Strong knowledge and experience with regulated clinical research environments, Computer System Validation, Good Clinical Practice, and software validation testing.
Experience with test management, bug tracking, document management systems, and test automation tools.
Ideal Candidate Profile
Experienced in managing validation activities in regulated clinical or healthcare software settings with strong operational ownership of testing processes.
Skilled in coordinating cross-functional and offshore teams with a focus on quality oversight, risk management, and meeting regulatory expectations.
Proficient in designing and executing comprehensive validation test cases across multiple testing types and maintaining compliance with audit readiness.