Position: QE3, Quality - Commercial Product Quality
Job description – Evaluate safety complaint escalations and make decisions on Medical Device(MDR) and Manufacturing Incidents(MIR) reporting, fully documenting those decisions. File MDRs/MIRs when needed and communicate as appropriate to the Authorized Representative or Regional Unit. Work with the Designated Complaint Handling Unit (DCU) and Medical Affairs to review and assess and close potentially adverse events (pMDRs), including MDR reporting related to IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems / Dimension Vista systems/Informatics systems.
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 and Medical Device Reporting.
Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
Good writing, communication and organizational skills necessary.
Key Working Relationships: Primarily intra organizational contacts and external contacts.
Job ID: 183988
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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