💪 Werde Design Quality Assurance Expert (m/f/d) bei Fresenius Medical Care und arbeite in Bad Homburg vor der Höhe – Bewirb dich jetzt

• Ensure that all design control deliverables comply with applicable regulatory requirements and design controls SOPs
• Provides input and guidance to design and development and design changes and take accountability for quality compliance as a member of the cross-functional project team representing Design Quality
• Review and approve all product development and change management projects compliance with Fresenius Quality Management System / SOP requirements by:
  • Review and approval of design control documentation
  • Design Review, Phase Exit Review and Milestone approval
  • Sample review of design control documentation during project execution
  • Independent compliance check through regular corporate audits
• Creation and monitoring of compliance metrics of design controls in development and design change activities
• Providing Management / Quality Review input for design & development

• Successfully completed university degree in a technical or scientific field, such as medical technology
• Several years of professional experience in research and development, regulatory affairs or quality management for medical devices or pharmaceuticals
• Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.)
• Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR § 820.250, etc.)
• Knowledge of CAPA methodology
• Excellent presentation and communication skills (fluent written and spoken English skills, German is an advantage), high engagement on achieving the targets and on the objectives, independent working structure
• IT skills in standard applications (especially MS Office), PDM Systems as PTC Windchill, QTRAK

Your contact

Fresenius Medical Care Deutschland GmbH
Reference number R0105809