Seeking a hands-on V&V Test Engineer responsible for executing validation protocols on medical device equipment. The role involves protocol-based testing, data recording, documentation, and ensuring compliance with quality and regulatory requirements.
Roles and Responsibilities
- Execute IQ/OQ/PQ validation protocols and follow detailed test procedures.
- Perform functional, operational, and performance testing of equipment.
- Set up test environments, equipment, and instruments as per protocol requirements.
- Record test results, observations, deviations, and validation evidence accurately.
- Identify, report, and support resolution of defects and non-conformances.
- Collaborate with Engineering and Quality teams for issue resolution and retesting activities.
- Ensure compliance with GxP, FDA 21 CFR Part 820/11, and ISO 13485 requirements.
- Maintain traceability, document control, and instrument calibration verification.
Preferred Qualifications
- Experience with medical equipment validation.
- Exposure to manufacturing or R&D laboratory environments.
- Strong documentation, analytical, and problem-solving skills.
Required Skills
- Hands-on testing experience in Medical Devices or regulated industries
- IQ/OQ/PQ Protocol Execution
- Protocol Reading and Step-by-Step Test Execution
- Test Data Recording and Documentation
- Equipment Validation
- GxP Validation Practices
- Lab Instruments (Multimeters, Oscilloscopes, Sensors, etc.)
- Defect Tracking and Reporting