Assures quality products and processes, and Quality Standard Compliance by establishing, enforcing and maintaining quality MAP and compliant QMS. Establishes and maintains a permanent improvement process of the QA Organization and of the Quality System. Ensures the full compliance of QA activities with FDA, QSR, ISO 13485, Corporate Policies and other quality system requirements. Management of QA staff, and be the Management Quality representative inside and outside the plant (Competent Authorities / Notified Bodies, etc). Be an active and effective part of the Management team of the Site.
Under direct supervision of the Senior Director of Quality Assurance & Compliance (Europe) and with a dotted line to the Plant Manager, in the Ireland Site