The Quality Process Auditor holds primary authority to independently plan, conduct, and report on internal and supplier audits of the Quality Management System (QMS) to verify ongoing compliance with 21 CFR 820 (QMSR), ISO 13485, EU MDR 2017/745, and other applicable regulatory and customer requirements. Regulatory and Certification Body Liaison Support Supports external audits and inspections (Notified Body, FDA, ISO certification bodies) by providing audit history, trend data, and QMS status, and may participate as a host or technical resource during external audits.