The ideal candidate must bring extensive hands-on medical device labeling experience with strong knowledge of FDA 21 CFR Part 801, EU MDR, ISO 13485, ISO 14971, UDI requirements, artwork/change control, labeling and printing process validation, CAPA, non-conformance investigations, and regulatory audit support. We are specifically looking for a very senior, hands-on Medical Device Labeling Quality Engineer / SME who has directly owned or supported labeling quality activities involving UDI, IFUs, artwork, labeling compliance, printing/label validation, CAPA, and audit readiness.