Labeling Specialist

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