Siemens HealthineersBusiness Unit:
Laboratory DiagnosticsRequisition Number:
United States-New York-TarrytownAssignment Category:
Full-time regularExperience Level:
Mid levelEducation Required Level:
Bachelor's DegreeTravel Required:
QE3 position: Represent and provide support for the Commercial Product Quality department when working on post market reagent, hardware and software related issues. 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. Provide Commercial Product Quality support for the IMMULITE and ADVIA Chemistry Reagent Product Health Teams. Good writing, communication and organizational skills necessary. Provide Commercial Product Quality support for external audits (LRQA, FDA, etc.). Expected to perform at a high level in the field of Commercial Product Quality and apply a high level of skills to resolved problems. Provide leadership and critical thinking in assessing and addressing pMDRs.
Demonstrate knowledge of the organization's business practices and issues faced and contributions to problem resolution of those issues. Experience in Quality Systems and MDR filing required.