V&V Test Engineer
Job Location:
Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
2 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
V&V Test Engineer
Irvine CA
Hire Type: Fulltime
Irvine CA
Hire Type: Fulltime
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
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). The role primarily involves protocol-based testing data recording and documentation to ensure equipment meets defined performance and regulatory requirements.
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
Protocol Execution
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
o ISO 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.
Protocol Execution
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
o ISO 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.
