Documentation Specialist

The Documentation Coordinator I will be responsible for maintaining the document control process, which includes making document changes, routing for review and approval, making documents effective, distributing documents and making notifications. In addition, the Documentation Coordinator I will be responsible for maintaining the training process, which includes keeping the training matrix current, routing training assignments, ensuring training has been completed and filing training records. Follow all procedures and work instructions defined in the Quality System Manual Documentation Review of document change orders to confirm all steps have been completed Process, implement and release document change orders Distribute controlled documents and remove obsolete revisions Coordinate training of revised documents Update technical files with document changes Create and/or update specifications, procedures, work instructions, forms and labels using Word and Excel in support of changes Support inspections and audits performed by FDA, Notified Body and customers Assists in compiling Design History Files Support agency listings and certifications: FDA, ISO 13485, MDSAP Support quality inspection department as needed Support manufacturing to keep product documentation accurate and up to date Support purchasing with complete documentation as required

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