New Quality Professional 2 Job in Newark, DE!
Position Title: Quality Professional 2

Position Number: 337613

Location: Newark, DE 19702

Position Type: Temporary

Required Skill Set:

FDA, Medical device, Problem Management, Quality Control

Position Description:

**C2C is not available**
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Job Title: Quality Professional 2
Location: Newark, DE, 19702
Duration: 12 Months
Schedule: Shift (8:30am - 5:00pm or 9:00am - 5:30pm)

• Evaluate safety complaint escalations and make decisions on Medical Device Reporting (MDR), fully documenting those decisions. File MDRs 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 Atellica/Dimension systems /Dimension Vista systems and assays/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 Atellica/Dimension/Dimension Vista systems and assays and Informatics system 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, issues faced and contributions to problem resolution of those issues.
• Experience in Quality Systems and Medical Device Reporting.

• BS/BA in Medical Technology, Biomedical Engineering or 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.

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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)
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