Medical Device Validation Engineer - IQ/OQ/PQ Specialist

QRC Group; Caguas (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

QRC Group in Caguas, Puerto Rico is seeking a Validation Engineer to support equipment validation activities in a medical device manufacturing environment (21 CFR Part 820 / ISO 13485). Focus on protocol execution, troubleshooting, and direct coordination with the client's team and equipment vendors.

The candidate will develop IQ/OQ/PQ protocols, perform deviations, and ensure compliance across the Validation Life Cycle.

Qualifications

• Bachelor's degree in Engineering required.
• Minimum 5 years validation experience in medical device/pharma.
• Hands-on IQ/OQ/PQ development and execution.
• Experience with cGMP and FDA 21 CFR Part 820.
• Strong written English skills (and Spanish).

Responsibilities

• Develop, execute, and close IQ/OQ/PQ protocols and reports.
• Troubleshoot equipment and drive issue resolution.
• Coordinate with client teams and vendors for support.
• Support full Validation Life Cycle including risk assessment and deviations.
• Assess validation impact of equipment changes and change control.

Skills

Troubleshooting

Technical writing

Bilingual EN/ES

Education

Bachelor's degree in Engineering

Job description

QRC Group in Caguas, Puerto Rico is seeking a Validation Engineer to support equipment validation activities in a medical device manufacturing environment (21 CFR Part 820 / ISO 13485). Focus on protocol execution, troubleshooting, and direct coordination with the client's team and equipment vendors.

The candidate will develop IQ/OQ/PQ protocols, perform deviations, and ensure compliance across the Validation Life Cycle.