Quality Engineer 1

Description:

Job description:
Evaluate safety complaint escalations, make decisions on MDR reporting, and documenting those decisions.
File MDRs when needed and communicate (as appropriate) to the Authorized Representative or Regional Unit.
Work with members of other teams to review, 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 (CPQ) 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 CPQ support for the above-mentioned systems Product Health Teams.
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.

Requirements:
2-3 years of experience with complaint handling and Medical Device Reporting (US and Outside of the US).
Good writing, communication and organizational skills necessary.
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.


Key Working Relationships: Primarily intra organizational contacts and external contacts.