Quality Systems Engineer II

Responsible for supporting and maintaining the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, industry standards, and internal procedures. Supports internal audits and external assessments, administers the electronic QMS, and provides quality systems training as needed. Oversees key quality processes, including CAPA, audits, nonconformances, change control, management review, quality planning, and gap assessments, while monitoring program effectiveness and communicating status and compliance risks to management.