Design Quality Assurance Expert

Vor 7 Tagen

Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

The Design Quality Assurance Expert (m/w/d) will be responsible to ensure the quality of design control activities for Active Medical Devices, supporting the project design and development to correctly realizing product development processes and complying with all specific requirements and applicable standards.

**Your assignments**:

- 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

**Your profile**:

- 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

**Our offer to you**:
There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (M/F/d) and how much experience you bring with you - for your professional future with meaning:

- The opportunity to work on a mobile basis, individually in consultation with your manager
- Whether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together
- A large number of committed people with a wide range of skills, talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company

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