Senior Labeling Quality Engineer / SME - Medical Devices
NTT DATA · Posted Nov 2, 2026
- Remote, United States
- Remote
- Senior
- 10+ years
Senior hands‑on Medical Device Labeling Quality Engineer / SME responsible for ensuring compliance of product labels, UDI, IFUs, artwork, and related documentation with global regulatory requirements.
Responsibilities
- Ensure compliance of labeling documentation with FDA 21 CFR Part 801, EU MDR, ISO 13485 and other regulations
- Review and approve product labels, IFUs, packaging inserts, artwork and other documentation
- Provide subject matter expertise for UDI requirements and barcode compliance
- Support labeling and printing process validation
- Lead CAPA and non‑conformance investigations
Requirements
- Nice to have: GS1
- Nice to have: HIBCC
- Nice to have: UDI databases
- Nice to have: Electronic artwork management
- Nice to have: Quality Management Systems