The Quality Engineer supports design output evaluations, maintains the Quality Management System, and manages risk assessment activities. They are also responsible for supplier qualification, CAPA updates, and ensuring compliance with regulatory standards during product development. Candidates must hold a B.S. in Mechanical Engineering or a related discipline and possess 2-5 years of experience in a Medical Device Quality Management System. Proficiency in ISO 13485, 21 CFR Part 820, and ISO 14971 is required, along with the ability to work in a manufacturing environment.
Galvanize provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
