- Greer, South Carolina, United States
- 3–5 years
Responsible for GMP, ISO, FDA compliance during project management and transition to manufacturing, ensuring customer specifications and inspection methods are understood and in compliance throughout engineering projects into production.
Responsibilities
- 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.
- Coordinates, develops, and writes product and custom equipment inspection and calibration plans for new and customer supplied molds.
- Help establish and implement strong quality systems, internal auditing, supplier approval, tooling PM, facility PM program, calibration, training and CAPA program.
- Evaluates product from DOE activities to prepare for and support parametric release and quality assurance.
Requirements
- Associate or Bachelor Degree preferred