Siemens Careers

Quality Systems RAQA

Tarrytown, New York
Quality Management

English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 231760
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 15%

Division Description:


Job Description:

Title: Quality Engineer, Level 4
Specific Requirements
Represent and provide support for the Commercial Product Quality department when working on post market Hematology, Syva, Hemostasis and Plasma Proteins reagent and instrument related issues from the Escalation Review Councils (ERC), as well as support and drive to closure Product Quality Committee (PQC) and Field Corrective Action decisions and reporting, as required, related to reagent and HW/SW 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 reagent and HW/SW Laboratory Diagnostics Product Health Teams. Provide Commercial Product Quality support for external audits (LRQA, FDA, etc.).  Expected to perform at an advanced level in the field of Commercial Product Quality and apply advanced skills to resolve 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, Medical Device Reporting and Field Action recommended.
Good writing, communication and organizational skills necessary.
Job Family Responsibilities: Performs root cause analysis and implementation of corrective action for process related concerns. Assist Quality manager in establishing, implementing and maintaining the quality management system. Develop training to build quality awareness. Conducts economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Develops and provides guidance to multiple operations for QMST. Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.

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.

General Requirements
Knowledge and Experience: Demonstrates and applies comprehensive knowledge of field of specialization to the successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues. Typically 8-10 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.

Direction of Others: Provides specialized guidance or train support and/or professional staff. Leadership qualities and role model qualities demonstrated.

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

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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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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