Serve as the primary point of contact for label changes and revisions.Work closely with Engineering to coordinate the release of label drawings and documentation.Create, update, and maintain digital label templates using Canva and other design or labeling platforms.Maintain accurate labeling databases, product information, and documentation in Excel.Support Quality change control processes for medical device labels, IFUs, and related documentation.Review label content, specifications, and project files for accuracy and compliance.Coordinate with translation services, printing vendors, and other external suppliers.Maintain accurate SAP ERP labeling data and ensure information is consistent across applicable systems.Review customer specifications and incorporate required labeling changes.Track label projects, revisions, approvals, and supporting documentation.Partner with Engineering, Quality, Manufacturing, and other departments to resolve labeling and documentation issues.Support continuous improvement initiatives related to labeling, documentation, and manufacturing processes.Assist plant personnel with labeling procedures, documentation requirements, and system-related questions.Maintain organized electronic files and records in accordance with company procedures.
1-4 years
Associate or Bachelor's Degree in Business, Engineering, Technical Communications, Quality, Manufacturing, or a related field.Previous experience in a medical device manufacturing environment.Direct experience with SAP ERP labeling workflows.Experience with labeling management software or specialized label design platforms.Experience using Canva or similar design tools for templates and technical documentation.Intermediate-to-advanced Excel skills, including formulas, data organization, and reporting.Experience supporting Engineering teams with drawings, specifications, revisions, or technical documentation.Knowledge of Quality Management Systems and document/change control procedures.Experience coordinating translations, print vendors, or external documentation suppliers.Familiarity with regulatory requirements related to medical device labeling and documentation.
High School Diploma or GED required.4+ years of experience in medical device documentation, labeling, quality documentation, regulatory coordination, or a related manufacturing environment.Experience managing product labels, technical documentation, or Instructions for Use (IFUs).Working knowledge of Excel, including maintaining databases, sorting/filtering data, and spreadsheet management.Experience working with ERP systems and maintaining product or manufacturing data.Ability to manage document revisions, approvals, and change control processes.Experience collaborating with Engineering, Quality, Manufacturing, or other cross-functional teams.Excellent attention to detail and ability to maintain accurate documentation.Ability to manage multiple projects, deadlines, and priorities.Effective written and verbal communication skills.
High School
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