This person is responsible for effective implementation and maintenance of Quality Systems and compliance programs in accordance with MDD 93/42/EEC, ISO 13485, CMDR, and applicable QSRs (21 CFR 820, 210, 211) for a specific plant or business unit. The role collaborates with teams responsible for CAPA, Complaints, Environmental Programs, Sterilization, Management Review, Change Control, Design Review, and manufacturing support to drive quality performance and continuous improvement.