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Quality Manager

  • Warszawa, mazowieckie
  • Kierownik
  • 02.10.2018

    Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

    HOLO SURGICAL S.A.

    Quality Manager

    Miejsce pracy: Warszawa

    Collaboration:

    • Such Quality Manager will be in direct and active collaboration with the project manager to create all the procedures and forms

    • Guide the developer team on preparing the design plan that meets the requirements for FDA and ISO 13485:2016.

    • There will be a direct contact with the CEO and CTO of the company

    • The team leaders and developers will be at reach to discuss suggestions and changes to the QMS
       

    Responsibilities and Tasks:

    • Supervise the creation of the Quality Management System for a surgical navigation system
    • Responsible for reviewing all manufacturing processes to identify those that need to be designated as special processes to identify those that need to be designated as special processes and that will require validation
    • Organize the different processes and forms in the cloud storage service related to the QMS
    • Risk management analysis

    Obligatory:

    • Experience on production of Quality Management Systems (2 years desired)

    • Advanced English equivalent to C1 level

    • University studies / certifications on medical device manufacturing, biomedical engineering, chemical engineering, mechanical engineering or related.

    • Organized, responsible, reliable and proactive

    • Team player

    Desired:

    • Basic knowledge on software validation

    • Knowledge on manufacturing processes and items related (for example: sterilization, disinfection, cleaning, welding, soldering, splicing, gluing, molding, casting of metals, coating, heat, radiation or chemical treatment of materials

    • Familiar with cloud storage systems to keep forms and documents organized online