Medical Device Labeling Specialist — Detail‑Driven

Nextern; Maple Grove (MN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Retirement plan with company match

Paid time off, personal days, and a生日休

Job summary

Nextern is seeking a Labeling Specialist to drive the design, validation, and implementation of labels for finished medical devices. You will ensure labeling aligns with risk management and regulatory requirements, support print stations, and sustain labeling activities across changes, CAPAs, and audits.

The role requires a degree in a related field and 3+ years in labeling, with strong knowledge of 21 CFR 820, ISO 13485, and ISO 14971.

Qualifications

• 3+ years of experience in a labeling role
• Experience with 21 CFR 820 and ISO 13485
• Understanding of ISO 14971 risk management
• Knowledge of medical device labeling requirements
• Understanding of configuration management for variable data
• Familiarity with labeling standards such as GS1 / HIBC barcodes
• Proficient in label design software
• Experience with PLM/ERP systems
• Strong written and verbal communication

Responsibilities

• Develop label designs across multiple programs
• Coordinate and execute label verification activities
• Support label print station qualifications
• Review and approve design changes to labels
• Lead labeling for new product launches and regulatory updates
• Liaise with label suppliers
• Serve as labeling SME for audits
• Draft labeling processes, guidelines, and forms in the Quality System
• Develop and validate label print artwork
• Maintain DHF and ensure batch information consistency across systems
• Interface between manufacturing/PLM and supply chain/ERP

Skills

Labeling expertise

Quality systems

Barcoding

PLM software

ERP software

MS Office

Education

Graphic design degree

Tools

BarTender

GSI Data Hub

Windchill

Agile

Propel

Epicor

NetSuite

Job description

Nextern is seeking a Labeling Specialist to drive the design, validation, and implementation of labels for finished medical devices. You will ensure labeling aligns with risk management and regulatory requirements, support print stations, and sustain labeling activities across changes, CAPAs, and audits.

The role requires a degree in a related field and 3+ years in labeling, with strong knowledge of 21 CFR 820, ISO 13485, and ISO 14971.