Labeling Specialist

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

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.

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

QUALIFICATIONS

Required:

• 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).

Preferred:

• Global experience preferred

Salary range: $70,000 to $100,000 per year depending on skills and experience

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nexternis an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.