Represent and provide support for the Commercial Product Quality department when working on post market ADVIA Centaur, ADVIA Chemistry, IMMULITE, Automation, Dimension, Vista and INFORMATICS instrument related issues. Evaluate safety complaint escalations and make decisions on MDR reporting, fully documenting those decisions.
Provide Commercial Product Quality support for external audits (LRQA, FDA, etc.).
Evaluate safety complaint escalations and make decisions on MDR reporting, fully documenting those decisions.
Provide support in all areas associated with MDR/MDVR reporting and trending.
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 and Medical Device Reporting.
**Experience with Medical Device Reporting required