Experience with Notified Bodies and CE Marking of Medical Devices Experience as a Medical Device Quality Auditor according to ISO 9001, ISO 13485, MDD and 21 CFR 820 Degree in biomedical, mechanical or process based engineering 5-8 years experience in the Medical Device Industry Experience of business related travel and cultural sensitivity Profound Knowledge in International Medical Device Regulations, incl. ISO 13485 and International Guidelines Proficient in design a and maintenance of quality systems Fluent English, German and third language preferable Human relations ability is a critical requirement for this position Ability to enter into highly different cultural and regulatory backgrounds worldwide with diplomatic sensitivity' Capability to present the results of the quality assessments to all levels of Local/Regional/Global Management Flexibility in approach and ability to adapt to changing circumstances when required Ability for cross functional work with other global functions Excellent team player, decision making and problem-solving skills Financial awareness of cost of quality to business Available for domestic and international travel (max. 30%)

Die Stellenanzeige Senior Quality Systems Manager & Notified Body Account Representative (m/f) von Fresenius Kabi Deutschland GmbH wurde zuletzt aktualisiert am 04.03.2016.

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