Description
The Medical Device Quality Engineer leads quality control programs, CAPA investigations, audits, inspections, validations, PPAP documentation, supplier quality, and continuous improvement in a medical device manufacturing environment. The role directs inspection and testing workers, trains quality and other departments, collaborates with engineering and suppliers, and may travel to facilities or customer and vendor sites. It requires five to seven years of medical device manufacturing and quality engineering experience or equivalent education and experience, with knowledge of ISO 13485, FDA 21 CFR 820, GD&T, and medical device testing standards.
