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International R&D Quality Manager (m/f) - Germany
Fresenius Medical Care (company)
Posted on : 20 March 2017
- 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
- 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.