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V&V Test Engineer
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Tata Consultancy Services Limited
Irvine, CA (In Person)
$85,000 Salary, Full-Time
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Job Description
Must Have Technical/Functional Skills
- 5+ years of hands-on testing experience in medical device or regulated industry
- Strong experience in: Executing
IQ/OQ/PQ
protocols, Protocol reading and step-by-step execution, Test data recording and documentation- Familiarity with: Lab instruments (multimeters, oscilloscopes, sensors, etc.), Equipment validation processes
- Understanding of GxP and validation practices
- Experience with Veritas Console or similar medical equipment
- Exposure to equipment validation in manufacturing or R&D labs Roles & Responsibilities We are looking for a hands-on V&V Test Engineer responsible for executing validation protocols on medical device equipment (Veritas Console).
- Execute pre-approved validation protocols (IQ/OQ/PQ) for medical equipment such as Veritas Console.
- Follow detailed step-by-step test procedures and ensure strict adherence to instructions.
- Set up test environments, instruments, and equipment as per protocol requirements. Testing Activities
- Perform functional, operational, and performance testing of equipment.
- Conduct tests under various conditions and scenarios defined in protocols.
- Capture accurate test results, observations, and evidence during execution. Documentation & Reporting
- Record test results in protocol documents, logbooks, and validation reports.
- Document any deviations, anomalies, or failures observed during testing.
- Ensure completeness and compliance of executed protocols per quality standards. Defect & Issue Handling
- Identify and report defects or non-conformances.
- Work closely with engineering and quality teams for issue resolution.
- Retest equipment after fixes as required. Compliance & Quality
- Ensure all activities comply with: o GxP guidelines o
FDA 21 CFR
Part 820 / 11 oISO 13485
- Maintain proper traceability and document control. Equipment Handling
- Operate and handle medical equipment, test setups, and measurement instruments safely.
- Ensure calibration status of instruments before testing.