Tasks performed regularly in addition to the main duties, but which do not determine the essential character of the position.

• 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.

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