Senior Medical Device Labeling Quality Engineer (Remote)

NTT DATA; Pittsburgh (Allegheny County); Remote; USD 120,000 - 160,000; Full time

Job summary

NTT DATA is seeking a Senior Labeling Quality Engineer / SME for medical devices in Pittsburgh. The role requires deep hands-on experience with labeling, UDI, IFUs, artwork, and regulatory compliance across global markets.

You will review labeling documentation, manage change controls, and support CAPA and audit readiness. A strong cross-functional collaboration mindset and precise attention to detail are essential.

Qualifications

• 10+ years of overall relevant experience in quality engineering and labeling for medical devices.
• 7+ years of extensive experience in medical device labeling (UDI, IFUs, artwork).
• 3–5 years of strong knowledge of FDA 21 CFR Part 801 and EU MDR.

Responsibilities

• Provide senior SME guidance on medical device labeling compliance.
• Review/approve labels, IFUs, artwork, and packaging for regulatory conformity.
• Lead CAPA, non-conformance investigations, and change control related to labeling.
• Support FDA inspections, Notified Body audits, and ISO 13485 activities.
• Collaborate with Regulatory Affairs, R&D, Manufacturing and Quality teams.

Skills

Labeling

UDI

IFU

Artwork

Regulatory Compliance

CAPA

Audit Readiness

Cross-functional Collaboration

Risk Management

Job description

NTT DATA is seeking a Senior Labeling Quality Engineer / SME for medical devices in Pittsburgh. The role requires deep hands-on experience with labeling, UDI, IFUs, artwork, and regulatory compliance across global markets.

You will review labeling documentation, manage change controls, and support CAPA and audit readiness. A strong cross-functional collaboration mindset and precise attention to detail are essential.