V&V Test Engineer

Veriipro; Irvine (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Veriipro is seeking a hands-on V&V Test Engineer in Irvine, California, responsible for executing validation protocols on medical device equipment. This role includes protocol-based testing, data recording, and ensuring compliance with quality and regulatory requirements.

Key responsibilities involve executing IQ/OQ/PQ validation protocols, performing functional and operational testing, collaborating with engineering and quality teams, and maintaining document control. Preferred qualifications include experience with medical equipment validation and strong analytical skills.

Qualifications

• Experience with medical equipment validation.
• Exposure to manufacturing or R&D laboratory environments.
• Strong documentation, analytical, and problem-solving skills.

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.

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

Job description

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