- Maintain Device Master Records (DMR) and Device History Records (DHR) located on and off site
- Process Pre-Released and Production Change Control packages and Work Instruction documentation
- Format and update St. Paul site Work Instructions
- Coordinate Change Control Process for St. Paul site Standard Operating Procedures (SOPs) and Departmental Procedures (DPs)
- Coordinate Change Control process for Divisional Policies (DVP), Divisional Procedures (DVSOP), and Divisional Departmental Procedures (DVDPs) globally for Smiths Medical sites
- Manage on and off site storage of records and assist internal customers with documentation retrieval, including offsite storage and related issues
- Provides guidance and support to internal customers
- Supports the Manager of Document Control
Position Description & Requirements:
Technical Knowledge and Skills:
- High School Diploma (or equivalent) and 3-5 years experience in a Medical Device organization or Document Control department
- Prefer experience to be applicable to standard Document and Data control activities in a Quality System regulated environment.
- Knowledge of FDA Quality System Regulation, ISO 13485, ISO 14001 and how they impact Document Control activities.
- Knowledge of and ability to use personal computers to operate company systems e.g. Oracle, SharePoint, MS Word, Excel, Access, Project, Adobe Acrobat, etc.
- Oracle experience desired
Smiths Medical - 18 months ago
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