Position Overview
Job Summary:
Validation Engineer – Manufacturing Operations responsible for overseeing complex production processes for surgical devices, leading validation activities, troubleshooting electro-mechanical systems, and ensuring manufacturing efficiency, compliance, and quality standards. Roles & Responsibilities: Oversee and optimize complex production processes for surgical devices to meet efficiency and quality standards. Serve as the primary technical expert for electro-mechanical equipment issues, perform root cause analysis, and implement corrective actions to reduce downtime. Lead development and execution of validation strategies including IQ/OQ/PQ for new and existing equipment. Apply Lean principles to identify waste reduction and improve process stability. Lead NCMR and CAPA investigations to maintain quality system compliance. Support adaptation of machine/equipment design to productio...