Fresenius Medical Care

  • Asheboro, NC, United States
Fresenius Medical Care Ogden, UT, USA
Position in Ogden, Utah. PRINCIPAL DUTIES AND RESPONSIBILITIES: 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 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,...