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International R&D Quality Manager (m/f) Bad Homburg Germany,  

Posted on : 20 March 2017

Project Description

/ CAREER WITH A PURPOSE / Fresenius Medical Care - Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products - that is Fresenius Medical Care. Your assignments Managing projects for the implementation of the FDA requirements in the existing quality management system for the GRD at the Schweinfurt and Bad Homburg sites. Coordinating interfaces for quality management system at other international sites Maintaining and improving the quality management system, on an ongoing basis, for the R&D department at the Schweinfurt site Producing implementation plans, carrying out instruction courses and checking the effectiveness of procedure instructions Preparing and coordinating internal and external quality audits (e.g. FDA) and tracking of corrective measures Representing the Global R&D QMS sub-processes in internal and external audits Creating, revising and maintaining procedure instructions (SOPs) in R&D Defining and implementing processes relevant to quality systems Your profile Studies in medical engineering or another engineering or scientific field and at least 3 years  professional experience, preferably in the area of product development or quality management Engineer with at least 8 years  professional experience in the area of quality management and/or product development Through knowledge of the requirements of the quality management system for medical products required (e.g. MDD, 21 CFR 820) Knowledge of the international approval of medical products an advantage Basic knowledge of development processes in medical technology Experience in staff training and in dealing with procedural instructions desirable High level of quality and process orientation Reliable and independent way of working, in particular as part of an international team Structured and targeted approach to troubleshooting as well as willingness to compromise Confident manner Assessment and decision-making ability Excellent communication Zus


61352 Bad Homburg Germany

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