V&V Test Engineer
Tata Consultancy Services · Irvine, CA · Yesterday
Engineering$80k–$90k/yrFull-time
Roles & Responsibilities
- We are looking for a hands-on V&V Test Engineer responsible for executing validation protocols on medical device equipment (Veritas Console).
- The role primarily involves protocol-based testing, data recording, and documentation to ensure equipment meets defined performance and regulatory requirements.
- Key Responsibilities:
- 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.
- Perform functional, operational, and performance testing of equipment.
- Capture accurate test results, observations, and evidence during execution.
- Document 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.
- Identify and report defects or non-conformances.
- Work closely with engineering and quality teams for issue resolution.
- Retest equipment after fixes as required.
- Ensure all activities comply with: GxP guidelines, FDA 21 CFR Part 820 / 11, ISO 13485.
- Maintain proper traceability and document control.
- Operate and handle medical equipment, test setups, and measurement instruments safely.
- Ensure calibration status of instruments before testing.
- BACHELOR OF COMPUTER SCIENCE
Qualifications
Pay
Salary Range: $80,000- $90,000 a year
Benefits
TCS Employee Benefits Summary
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.