8 часов назад
Label Designer (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Label Designer (Medical Devices): Creating and controlling product labels, packaging artwork, and regulated documentation for a medical device production plant with an accent on UDI data, regulatory requirements, and revision control. Focus on verifying label content, maintaining labeling templates and databases, and coordinating changes across Quality, Regulatory, Engineering, Marketing, and Production.
Location: Athens, Texas, United States; onsite at the Athens Production Plant
Company
is a global manufacturer of specialty medical products for interventional radiology, vascular surgery, interventional cardiology, and oncology.
What you will do
- Process, distribute, file, maintain, and control released documentation.
- Create, revise, and maintain product labels, labeling specifications, packaging artwork, and templates.
- Generate and update labeling content according to approved specifications, engineering changes, and Quality System requirements.
- Verify part numbers, catalog numbers, lot and batch information, UDI data, symbols, translations, and regulatory content.
- Maintain tracking databases and generate document distribution reports using QAD, label programs, or other approved systems.
- Coordinate labeling changes, product introductions, and production support with Document Control, Regulatory, Quality, Marketing, Engineering, and Production.
Requirements
- High school diploma or higher; an associate degree is preferred.
- Experience with QAD or similar MRP software and BarTender or equivalent label design software.
- Knowledge of medical device Quality Systems, document control, change management, and revision control.
- Experience creating and maintaining product labeling in a regulated environment.
- Understanding of medical device labeling requirements, UDI, FDA, ISO 13485, and applicable regulatory requirements.
- Ability to coordinate with personnel across departments and support efficient product introduction and documentation flow.
Culture & Benefits
- Work supports specialty medical products designed to improve patient outcomes through percutaneous, image-guided procedures.
- Cross-functional collaboration across Regulatory, Quality, Marketing, Engineering, Production, and Document Control.
- Light physical demands.
- No travel required.
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