Represent and provide support for the Commercial Product Quality department when working on post market, Atellica CH and ADVIA Chemistry reagent and consumables, and Hardware/Software related issues from the Escalation Review Councils (ERC), as well as support and drive to closure Product Quality Committee (PQC) and Field 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 Atellica CH and ADVIA Chemistry reagent and consumable 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.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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