Quality Engineer (MDR - Medical Device reporting)

 | Description:  Evaluate safety complaint escalations and make decisions on MDR reporting, fully documenting those decisions. File MDR’s when needed and communicate as appropriate to the Authorized Representative or Regional Unit. Work with Headquarters Support Center (HSC), the Designated Complaint Handling Unit (DCU) and Medical Affairs to review and assess and close potentially adverse events (pMDR's) including MDR and Field Corrective Action decisions and MDR reporting related to IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems / Dimension Vista systems/Informatics systems and IMMULITE /ADVIA Chemistry reagents. Provide support in all areas associated with MDR/MDVR/MDPR reporting and trending. In addition, support the Commercial Product Quality department when working on post market IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems / Dimension Vista systems/Informatics systems related issues from the Escalation Review Council (ERC). 
 Provide Commercial Product Quality support for the above mentioned systems Product Health Teams. 
 Provide Commercial Product Quality support for external audits (LRQA, FDA, etc.). 
 Display of a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems is expected. Demonstrate a significant knowledge of organization's business practices and issues faced and contributions to problem resolution of those issues. 
 
 Experience in Quality Systems, Medical Device Reporting. 
 
 Good writing, communication and organizational skills necessary. 

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