Labeling Specialist

Job Title : Labeling Specialist

Location : Plymouth MN Hybrid, Also open to Colorado Springs

Experience : 5+ years

Duration : 12+ month contract with possible extension

Job Summary

This role focuses on creating, updating, and managing product labeling and packaging for medical devices. The work supports Image Guided Therapy products and must follow GMP, FDA regulations, EU MDR, ISO requirements, and internal quality procedures. The position requires high attention to detail, strong coordination skills, and the ability to work across multiple teams.

Responsibilities

Develop and maintain Instruction for Use documents, including illustrations, layout designs, and written content.

Create or revise labeling artwork using tools such as Bartender, Adobe LiveCycle, EnLabel, and other template-based platforms following established design and company standards.

Manage labeling documentation through PLM systems such as Windchill to ensure proper routing, approval, and version control.

Perform prepress tasks to ensure all artwork files are prepared accurately for production output.

Prepare and route complete labeling packages for first article reviews and final approvals.

Proofread and verify labeling accuracy using measurement tools, barcode scanners, and reference documentation.

Maintain a strong focus on first-time-right quality with minimal errors in all labeling work.

Review and update all labeling content as needed to uphold correct revision control and secure storage.

Collaborate with multiple teams including manufacturing, engineering, regulatory, legal, product development, and marketing to complete labeling assignments.

Support NCR and CAPA processes by investigating issues, identifying root causes, and implementing corrective actions.

Contribute to continuous improvement by updating documentation and enhancing labeling processes.

Follow all compliance, documentation, and quality system requirements consistently.

Required Skills and Experience

Bachelor's degree or equivalent relevant experience.

Strong proficiency with Adobe Creative Suite and Microsoft Office.

Experience with Adobe LiveCycle is preferred.

Exposure to Bartender, EnLabel, Windchill, and SAP is considered an advantage.

Understanding of regulatory standards such as FDA requirements, EU MDR, ISO standards, and other global regulations is helpful.

Excellent written and verbal communication skills.

Strong ability to prioritize, organize workflow, and work independently within company guidelines.

Comfortable interacting with teams at all levels, including senior leadership.

Fast learner who can adapt to new software, tools, and evolving processes.

Exceptional attention to detail and commitment to accuracy.