Labeling Specialist

Nextern•Maple Grove, MN

4d•$70,000 - $100,000

About The Position

At Nextern, we inspire with passion, impact with significance, and act with integrity. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide. This role is responsible for the development, validation, and implementation of label designs for finished medical devices developed by Nextern. Labeling Specialists are members of product development teams, utilizing their expertise to develop label designs aligning with device risk management files and relevant regulatory requirements, identify label printing process controls to ensure printed content is accurate, and ultimately transfer into commercial manufacturing. This role is also responsible for sustaining activities related to labeling including, but not limited to: changes and impact assessments, global regulatory compliance, nonconformances and complaints, and process improvement. All functions are responsible for compliance with the Quality System, regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.

Requirements

Degree in graphic design, communication, business, or equivalent
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 (e.g. GS1, HIBC-128)
Proficient in label design and management software (e.g. BarTender, GSI Data Hub)
High attention to detail, organization, and accuracy
Instinctual capability for creative thinking and proposing novel solutions
Strong ability to communicate (written and verbally) within and across disciplines and organization structures.
Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..).
Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
Experience with Enterprise Resource Planning (ERP) software (e.g. Epicor, Net Suite)
Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook).

Nice To Haves

Global experience preferred

Responsibilities

Development project team member accountable for label design across several programs simultaneously
Coordinate and execute, as necessary, label verification activities
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
Liaison to label raw material and equipment suppliers
Serve as organizational SME for labeling requirements, including audits
Draft/own labeling processes, guidelines, templates, and forms within the Quality System
Develop and validate, as necessary, label print artwork files and printing process
Create and maintain up-to-date product Design History Files (DHF)
Interface between manufacturing/PLM and supply chain/ERP ensuring batch specific (i.e. lot/serial number) information is accurate across systems