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Quality Engineer - Medical Device Reporting

Ampcus, Inc
United States, New York, Tarrytown
Aug 29, 2024

Supports the compliance with normative necessities as a codes and standards manager, procures and manages relevant codes and standards, provides them to the engineering organization and, if necessary, informs about changes.

Manages and coordinates the maintenance of procedures and work instructions for Engineering.

Issues the requirements for change request management in the projects and provides if necessary suitable methods.

Provides procedural support for the engineering organization at e.g.: -

Creation of quality notifications - Provision, maintenance and evaluation of processes (e.g. Client, capa), together with the Quality-organization - Planning and execution of design reviews in cooperation with the QMiP - Planning and execution of internal projects (e.g. lean) or events (e.g. capa) - ISO 9000 certifications; Quality audits; supplier qualifications.* Acts independently from project management (PM@Siemens).* May actively execute or initiate internal quality measures (e.g. formal checks of data bases or documentations)..

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