Design Assurance Engineer
, , Italy
Design Assurance Engineer page is loaded Design Assurance Engineer Apply locations CREMONA, Cremona, Italy time type Full time posted on Posted 2 Days Ago job requisition id R0144022 Tasks performed regularly which form the essential characteristics of the position.
Ensure that all design control deliverables comply with applicable regulatory requirements and design controls SOPs
Prepare together with Project Manager’s the design and development documentation for project and for design control activities
Support Product Center/Project Manager to get part of DHF needed to Medical Device Compliance and Regulatory Affairs to complete Technical Dossier/Registration dossier
Provide Training on design & development relevant quality requirements
Provide input to design and development and design changes and take accountability for quality compliance as a member of the cross-functional project team representing Product Center for Design Quality part.
Review and approve all product development and Design Change projects in compliance with Fresenius Quality Management System / SOP requirements by:
Preparation / Review and approval of applicable design control documentation
Design Review, Phase Exit Review and Milestone approval
Preparation of applicable document and sample review of design control documentation during project execution
Quality Approver for Design and Development related NC/CAPA
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