
Packaging Documentation Coordinator
2 days ago
This role involves overseeing labeling databases, tracking issues, and maintaining Quality Systems Records (QSR) for customer labeling, specifications, and documentation.
Key responsibilities include managing documents in compliance with ISO, cGMP, and FDA guidelines, change control, engineering change requests, collaborative review processes, and maintaining revision control.
The ideal candidate will possess strong self-motivation, excellent communication skills, and the ability to work independently and in a team environment.
Required knowledge includes proficiency in Microsoft Office's suite of products and 3+ years of hands-on experience in a medical device document controller role.
- Manage labeling databases and track issues
- Maintain QSR and related materials
- Control document changes through established formats and templates
- Initiate collaborative review processes
- Track documentation through development process
- Knowledge of Microsoft Office's suite of products
- 3+ years of hands-on experience in medical device document controller role
- Strong self-motivation and ability to work independently and in a team environment
- Excellent communication skills
- Ability to manage multiple priorities simultaneously
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