Label Designer
On-siteAthens, Texas, United States
Job Summary
Process, distribute, and maintain controlled documentation, labels, and packaging artwork in accordance with Quality System and Regulatory requirements. Create, revise, and verify labeling content including part numbers, UDI data, and symbols while ensuring accuracy across product families. Coordinate with Document Control, Regulatory, Quality, Marketing, Engineering, and Production to support labeling changes, product introductions, and ongoing production activities. Manage databases to track document distribution and generate reports using QAD, label programs, or other approved systems. Ensure all documentation and labeling projects meet established deadlines within the Athens Production Plant.
Required Qualifications
- High school diploma or higher
- Experience using QAD or similar MRP software
- Knowledge of Medical Device Quality Systems
- Knowledge of BarTender software or equivalent label design software
- Strong attention to detail and accuracy
- Excellent written and verbal communication skills
- Good PC skills in a Windows environment, specifically Word, Excel, and Access
- Familiarity with graphical manipulation using software programs
- Knowledge of document control, change management, and revision control processes
- Understanding of medical device labeling requirements and Quality System regulations
- Experience creating and maintaining product labeling within a regulated environment
- Ability to interface with personnel across departments to support efficient product introduction and documentation flow
- Self-starter with the ability to work with minimal supervision
- Good time management skills with the ability to prioritize using sound judgment
Desired Qualifications
- Associate degree preferred
- Experience with medical device labeling and UDI requirements
- Experience generating and maintaining production labels and labeling specifications
- Knowledge of FDA, ISO 13485, and other applicable regulatory requirements related to labeling
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