Design Assurance Engineer

Goal of function:

Assure the quality of design control activities and correctly realizing product development processes;

Maintenance of product compliance.

Main tasks:

- 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

Requirements

Required educational background:

Technical/Engineering / Scientific background (degree)

Required professional experience:

Experience of minimum 2-3 years in Regulatory Affair in pharmaceutical/medical field

Technical knowledge:

• 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 internal and external processes and structures and of the corporate Quality Management requirements

• Knowledge of CAPA methodology

• Knowledge in statistical methods

Good knowledge of English is required.