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International R&D Quality Manager (m/f) - Germany  

Fresenius Medical Care (company)


Posted on : 20 March 2017

Project Description

Your Assignments        
  • Managing projects for the implementation of the FDA requirements in the existing quality management system for the GRD.
  • 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.
  • 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       

Career with a purpose:       
  • Over 200,000 people across the globe work at our company  to provide better medicine for more people. 
  • We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
  • Our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.     
  • Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.