Quality Engineer

Evaluate requirements and design documents to provide prompt feedback to customers, then develop validation plans using IQ OQ PQ structure to ensure compliance with regulations and internal requirements. Plan validation activities, complete all documentation, and execute FEMAs risk assessments with internal and external teams. Use quality tools to analyze data, identify improvement areas, and apply problem-solving techniques while supporting new product development and production. This role requires four years of Quality Engineer experience, extensive injection molding background, and preferred medical industry and ISO 13485 exposure.