Siemens Careers

Quality Systems RAQA

Tarrytown, New York
Quality Management

English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 231758
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Division Description:


Job Description:

Represent and provide support for the Commercial Product Quality department when working on post market reagent, hardware and software related issues for the Hematology, Hemostasis and Plasma Proteins product lines. 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.  Good writing, communication and organizational skills necessary. Provide Commercial Product Quality support for external audits (LRQA, FDA, etc.).  Expected to perform at a high level in the field of Commercial Product Quality and apply a high level of skills to resolve problems. Provide leadership and critical thinking in assessing and addressing pMDRs.
Demonstrate knowledge of the organization's business practices and issues faced and contributions to problem resolution of those issues. Experience in Quality Systems and Medical Device Report filing recommended.

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

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