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Quality Management System Specialist

  • Szczecin, zachodniopomorskie pokaż mapę
  • Specjalista
  • 04.07.2018

    Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

    Quality Management System Specialist
    Miejsce pracy: Szczecin

    3Shape’s business is constantly growing and becoming more and more complex, the same goes for the production in 3Shape Poland Sp. z o.o. in Szczecin.
    To support this development, we seek a Quality Management System Specialist.

    Quality Management System led by Global QMS team located in Szczecin, is an integral part of 3Shape Group functionality and is valid in all locations, all over the world. As a system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, our goal is to continuously improve the effectiveness and efficiency within the company.
    QMS helps to coordinate organization activities to meet both customer and regulatory requirements and improve its effectiveness and efficiency on daily basis and based on ISO 13485:2016, FDA 21 CFR 820 and other requirements.

    Your Profile

    • At least two years of relevant experience in QMS
    • Previous experience in ISO13485 is required
    • Experience in FDA, GMP and UDI system (an advantage)
    • Experience as an internal auditor (Certified Internal Auditor ISO13485)
    • Experience with external ISO13485 audits or FDA inspection will be an advantage
    • Very good English, both verbally and writing (essential condition);
    • Good knowledge Excel and PowerPoint
    • You pay attention to details together with an analytical way of thinking
    • Organized, flexible, communicative

    Your Responsibility:

    • Active part in the standardization processes across global organisation in Poland, Denmark, US and China – Global QMS
    • CAPA and Engineering Change Order systems work with
    • Internal audits and team work within external audits and inspections (Poland and Denmark)
    • Creation of quality documentation
    • Cooperation with several departments in all aspects connected with quality assurance
    • Active participation in the projects related to the Quality Management System
    • Cooperation with Denmark Headquarter (travel max. around 20-30 days per year)

    We offer:

    • Job in a leading global Company.
    • Participation in creating market-leading technology products for customers around the world.
    • Lots of interesting challenges that will require your technical, analytical and communicative skills.
    • Personal growth and development.
    • Work in unique professional, friendly and supportive environment.
    • English or German classes.
    • Company events.

     We will be glad to welcome you in our team!

     Please note that only resumes in English will be considered.


    Please add consent for processing personal data included: In accordance with the Law of Personal Data Protection of 29.08.1997 (Journal of Laws No. 133, item 883) I give my consent to processing of my personal data contained in my application for the purpose of current and future recruitment process within 3Shape Group.

    In accordance with art. 24 sec. 1 of the Act of 29 August 1997 on the Protection of Personal Data (Journal of Laws of 2002, No. 101, item 926, as amended), we inform you that the administrator of personal data provided by you voluntarily to conduct current and future recruitment is 3Shape Poland Sp. z o. o. with headquarters in Szczecin 70-033, at Zapadła 8d. You have the right to access, correct and delete your personal data. Please be advised that, apart from the entities authorized under the law, the collected personal data will not be made available. Your personal data will be kept for a period of 12 months.

    Please be informed that the 3Shape Poland Sp. z o. o.  uses closed circuit television (CCTV) images to provide a safe and secure environment for employees and for visitors to the 3Shape Poland Sp. z o. o. business premises as well as to protect the 3Shape Poland Sp. z o. o. property and assets. The CCTV system may be used to investigate security incidents in order to secure evidence, should such incidents occur. All footage gathered is stored no longer than 30 days. The images that are filmed are recorded centrally and held in a secure location.