Description
- Batch Record Review Experience
- Provides status metrics of complaints throughout the process to the organization on a weekly basis.
- Performs product decontamination & assists engineers with product investigations.
- Including product measurements of returned devices simulated testing & will capture this information in the file.
- Performs lot history record review for every complaint report & updates the file as appropriate.
- Provides support during all regulatory inspections, including FDA, ISO Notified Body & internal audits.
- Stays Current with Domestic & International Regulatory requirements.
- Coordinates &-or performs complaint file completion including; initial receipt, tracking, processing & reporting assessment, Lot History Review, assists with complaint investigations & procures approval signatures for closure & filing.
- Maintains complaint files, & database, completing complaint reports after evaluation by engineers
To find out more about Real please visit www.realstaffing.com