Description
The Medical Device Quality Engineer will support manufacturing quality operations in a medical device environment, ensuring products, processes, and components meet specifications. The role leads device history record reviews, nonconformance and CAPA investigations, PFMEA and control plan development, process and equipment validation, quality-system improvements, customer feedback investigations, and engineering change orders. It requires daily coordination with production, engineering, materials, and quality teams, along with knowledge of 21 CFR 820 and ISO 13485:2016, statistical analysis, project management, and technical communication. The position requires at least five years of medical-device manufacturing experience in a QMS environment and a bachelor’s degree or equivalent experience in manufacturing, mechanical, or related engineering or life sciences.
