To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
- Documentation management, including processing, distribution and filing of all documents associated with medical devices using the Integra 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 critically 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
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.