Design Quality Assurance

In your role as DQA & MD Compliance Expert (M/F/d) you will be responsible for assure the quality of design control activities and correctly realizing product development processes and maintenance of product compliance.

Your assignments
- 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
- 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.

**Profile**:

- Technical / Scientific background (degree)
- Experience of 2-3 years in Regulatory Affairs or Quality environment in pharmaceutical/medical field
- Experience in R&D
- Good and professional relationship to and communication with international colleagues and superiors.
- High engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work cross functional with all levels of employees
- Autonomy in decision making
- Good knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.) and 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 and statistical methods
- Experience in project management will be a plus
- IT user skills in MS Office (TrackWise Workflow or Windchill PDM systems are an advantage)
- Fluent in English (written and spoken)

Our offer to you
- We offer permanent contract, the remuneration will be commensurate with the experience
- Auf einen Blick- Standort:
- InternationalPalazzo Pignano- Karrierelevel:
- Berufserfahrene- Einsatzbereich:
- Regulatory Affairs / Safety- Arbeitsverhältnis:
- UnbefristetVollzeit- Unternehmen:
- Fresenius Medical Care- Referenznummer:
- 56384- Veröffentlicht am:
- 26.04.2023- Solange die Stellenanzeige online ist, können Sie sich schnell und einfach bewerben.