Label Designer

Argon Medical Devices, Inc.; Athens (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

Argon Medical Devices, Inc. seeks a Label Designer to support the Athens Production Plant by managing controlled documentation and product labeling activities in line with Quality System and regulatory requirements.

You will process, revise, and control labeling content, coordinate with Regulatory, Quality, Marketing, Engineering, and Production to ensure accurate releases and timely support for product development and production changes.

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
• 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.

Responsibilities

• 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.

Job description

Company Overview:

Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

Position 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.

What you will do:

• 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.

Skills for Success:

• 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
• 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.

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