Quality Engineer I

Job Summary

The Quality Engineer I facilitates regulatory compliance at the North Tonawanda, NY facility pertaining to 21 CFR Parts 210, 211, and applicable sections of 820. The role supports closure and monitoring of internal investigations, contributes to effectiveness and sustainability of the site’s QMS, and helps ensure product quality, regulatory compliance, inspection readiness, and data integrity. This role performs quality engineering activities of basic to moderate complexity under established procedures and guidance from senior quality staff, while continuing to develop technical, regulatory, and critical‑thinking proficiency in a regulated manufacturing environment.