- Documentation management, including processing, distribution and filing of all documents associated with medical devices using the Document Management System
- Initiation of change requests for new and amended documents.
- Routing of controlled documents through the approval and implementation process.
- Issue and maintenance of controlled documentation.
- Report to Management on document Control metrics as required.
- Management of the training files per department and generation and maintenance of training matrices
- Management of train track system
- DHR filings – management and transfer to off site storage as required
- Minimum of 2 years’ experience working within a QA function in an FDA or ISO 13485 regulated Industry.
- Demonstrated understanding of criticality of attention to detail, data accuracy and document control
- Must have the ability to communicate effectively with management and fellow peers
- experience with Oracle; Agile and Access a distinct advantage.
For a confidential discussion and more information on the role, please contact Tina Egan