Labeling Specialist

Nextern•Maple Grove, MN

About The Position

At Nextern, Labeling Specialists develop, validate, and implement label designs for finished medical devices. They work as members of product development teams, applying labeling expertise to align designs with device risk management files and regulatory requirements, establish controls for accurate label printing, and support transfer into commercial manufacturing. The role also handles sustaining labeling activities, including changes and impact assessments, global regulatory compliance, nonconformances and complaints, and process improvement. The position supports compliance with the Quality System, regulations, and standards, continuous improvement, and professional interaction with Nextern customers as needed.

Requirements

Degree in graphic design, communication, business, or equivalent.
At least 3 years of experience in a Labeling Specialist role.
Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.
Understanding of ISO 14971 and application of risk management to product development and processes.
Familiarity with medical-device-industry-specific labeling requirements.
Understanding of configuration management in relation to variable data and label templates.
Familiarity with harmonized and recognized test standards for labeling.
Experience using barcoding systems such as GS1 or HIBC-128.
Proficiency in label design and management software such as BarTender or GSI Data Hub.
High attention to detail, organization, and accuracy.
Capability for creative thinking and proposing novel solutions.
Strong written and verbal communication skills across disciplines and organizational structures.
Demonstrated use of quality tools and methodologies, such as nonconformance, CAPAs, and root cause analysis.
Experience with Product Lifecycle Management (PLM) software such as Windchill, Agile, or Propel.
Experience with Enterprise Resource Planning (ERP) software such as Epicor or NetSuite.
Intermediate to advanced proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, Project, and Outlook.

Nice To Haves

Global experience.

Responsibilities

Serve as a development project team member accountable for label design across several programs simultaneously.
Coordinate and execute label verification activities as necessary.
Support label print station qualifications.
Review, assess, and approve design and process changes to existing package and label designs or processes.
Lead and coordinate labeling activities for new product launches, market expansions, and regulatory updates across departments.
Act as liaison to label raw material and equipment suppliers.
Serve as the organizational subject matter expert for labeling requirements, including during audits.
Draft and own labeling processes, guidelines, templates, and forms within the Quality System.
Develop and validate label print artwork files and printing processes as necessary.
Create and maintain up-to-date product Design History Files (DHF).
Interface between manufacturing/PLM and supply chain/ERP to ensure batch-specific information, such as lot or serial numbers, is accurate across systems.