Quality Systems Analyst 3

Quality Systems Analyst 3
Duration:6+ months with possible extension
Location: Newark-DE

The Quality Analyst 3 will be responsible to support in the creation and maintenance of Quality System documentation and records related to Field Actions, Adverse Event Reporting, Product Quality and others to support various regulatory requirements (Food and Drugs Administration (FDA), IVDR (In Vitro Diagnostics Medical Device Regulation) and other external regulations and laws. Support Siemens Healthineers Laboratory Diagnostics (LD) Commercial Product Quality (CPQ) in updating and creating procedures, processes records and guidance’s that are fully compliant with all applicable regulations for LD post market activities. Carries out complex to semi-complex Medical Devices and In Vitro Medical Device regulations compliance assignments while ensuring assigned Projects are on schedule. Participates in the implementation of procedures, presentations and training to various functional groups in the Quality and Technology LD Business Area and other groups. Identifies and resolves issues by applying problem solving skills. Displays effective use and application of the Quality and Compliance concepts to successfully generate and analyze quality data from internal and external sources. Demonstrate knowledge of LD organization's business practices and procedures and demonstrate knowledge of the quality function through successful completion of assignments. Experience in Quality Systems, Medical Device Adverse Event Reporting, Field Actions, Document Controls and Product Quality Issues. Collaborate and communicate effectively cross functionally to review and assess LD CPQ assigned projects and tasks are executed in compliance with schedules.

Thanks and Regards,
Ali Khan
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560                                                                                                                 
Direct: 510.870.8798 | Fax: 510.623.5055 | ali@apninc.com 


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