Siemens HealthineersBusiness Unit:
Laboratory DiagnosticsRequisition Number:
United States-New York-TarrytownAssignment Category:
Full-time regularExperience Level:
Mid levelEducation Required Level:
Bachelor's DegreeTravel Required:
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
For more information, please visit: http://www.usa.siemens.com/healthineersJob Description:
Represent and provide support for the Commercial Product Quality department when working on post market, ADVIA Chemistry, IMMULITE and Atellica CH reagent/consumable/Hardware/Software related issues from the Escalation Review Councils (ERC), as well as support and drive to closure Product Quality Committee (PQC) and Field Corrective Action decisions and reporting as required related to these Laboratory Diagnostics products. 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 ADVIA Chemistry, IMMULITE and Atellica CH reagent/consumables Product Health Teams. Provide Commercial Product Quality support for external audits (MDSAP, FDA, etc.). Expected to perform at an advanced level in the field of Commercial Product Quality and apply advanced skills to resolved complex problems. Provide leadership to the Product Quality Committee in assessing and addressing product defects.
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, including CAPA, and Medical Device Reporting and Field Action recommended. Good writing, communication and organizational skills necessary.