- Creation and monitoring of compliance metrics of design controls in development and change management activities
- Additional tasks due to main duties:
- Audit support of design and development sessions
- Providing management quality review inputs for Design and development
- MD Compliance Expert: support of Product Center in writing MDR Technical Documentation and related documentation.
- 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
Design Assurance Engineer 1 - Reynosa, Tamps., México - Fresenius Kidney Care
Descripción
Design Assurance Engineer 1 page is loaded
Design Assurance Engineer 1
Apply locations Reynosa, TAMPS, MEX time type Full time posted on Posted Today job requisition id RTasks performed regularly in addition to the main duties, but which do not determine the essential character of the position.
Tasks performed regularly which form the essential characteristics of the position.
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