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Position Summary Responsible for GMP, ISO, FDA compliance as applicable during project management and transition to manufacturing, assures customer specification and inspection methods are understood and in compliance throughout engineering project into production.  Responsible for auditing quality system. Primary Functions Interfaces with customers along with Quality Manager to understand and communicate product requirements and inspection requirements for new and customer supplied mold projects. Develops and executes procedures for product and equipment Process Validations (Installation Qualification – IQ, Operational Qualification – OQ, Performance Qualification – PQ) of new and customer supplied molds. Co