Quality & Regulatory Compliance Manager (f/m/x)

Carl Zeiss AG - Jobangebot

Connecticum Job-Nr. 1415720
  • Arbeitgeber: Carl Zeiss AG Firmenprofil
    Beschäftigungsart: Professionals Job
    Jobdatum: 21. Juli 2021
    Fachbereiche: Ingenieurwissenschaften: Allg. Ingenieurwissenschaften
    Einsatzort: Aalen; Baden-Württemberg

    Quality & Regulatory Compliance Manager (f/m/x) - Jobangebot

    Quality & Regulatory Compliance Manager (f/m/x)
    Aalen
    Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.
    You will:
    • establish and maintain the quality management system
    • create and maintain technical documentations
    • guide the R&D process from quality & regulatory compliance perspective
    • lead CE registration and/or US equivalents and supporting product registration for other countries and regions
    • lead the transition to new standards and regulations, such as MDR
    • communicate with notify body and authorities, and escorting external audit
    • follow up CAPA
    Your Profile:
    • a bachelor degree in engineering, optics, electrical, mechanical, medical device
    • more than 3 years quality and regulatory experience in production and R&D environment
    • familiar with the requirement of ISO13485, have internal auditor certificate
    • experience in establishing and maintaining quality management system
    • experience in creating and maintaining technical documentation
    • familiar with the requirement of EU and US medical device regulatory requirements
    • good at coordination, communication and problem solving
    • fluent spoken and written English and German
    Tooz technologies – a joint venture of Deutsche Telekom AG and Carl Zeiss AG – develops technologies and applications for data glasses. In this legally independent joint venture of the two companies, technology and application development has been pooled at the sites in Aalen.

    Thrive on innovation and deliver exciting solutions in a fast-paced work environment at this venture. We offer you the possibility to contribute in building great technology and in delivering an exciting user experience! Join us and be part of an open and inspiring culture together with excellent colleagues!
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Quality & Regulatory Compliance Manager (f/m/x)

Jobkennzeichen Connecticum Job-Nr. 1415720
Kontaktdaten:
Arbeitgeber-Profil: ZEISS