Job Description
Job Overview:
The Label Designer supports the Athens Production Plant by managing controlled documentation and product labeling activities in accordance with applicable Quality System and Regulatory requirements.
This role is responsible for processing, distributing, maintaining, creating, revising, verifying, and controlling documentation, labels, and packaging artwork. The position works cross-functionally with Document Control, Regulatory, Quality, Marketing, Engineering, and Production to ensure accurate information is released in an efficient and timely manner to support product development, labeling changes, and ongoing production activities.
Essential Functions
- Process, copy, distribute, file, and maintain controlled documentation upon release.
- Maintain, issue, and update documents and labels using QAD, label programs, or other approved systems.
- Create and maintain databases necessary to track document distribution and generate reports.
- Create, revise, maintain, and control product labeling documents, including product labels and labeling specifications.
- Generate and update labeling content in accordance with approved specifications, engineering changes, and Quality System requirements.
- Verify label content for accuracy, including part numbers, catalog numbers, lot/batch information, UDI data, symbols, translations, and regulatory requirements.
- Maintain labeling templates and support consistency across product families and product lines.
- Coordinate with Regulatory, Quality, Marketing, Engineering, Production, and Document Control to support labeling changes, product introduction, and ongoing production needs.
- Ensure documentation and labeling projects meet established deadlines.
- Perform other duties as assigned.
Competencies
- 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.
Supervisory responsibilities
- N/A
Required Education and Experience
- 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.
Preferred Education and Experience
- 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.
Physical demands & Travel required
- Light
- No travel required
