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אייסקיור מדיקל בע"מ

    דרושים אייסקיור מדיקל בע"מ

    תחום עיסוק
    הייטק / חומרה / תוכנה / סייבר
    כמות עובדים
    1-10

    עוד עלינו

    דרושים ב- אייסקיור מדיקל בע"מ

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    המימד השלישי
    Location: Caesarea
    Job Type: Full Time and Travel Required
    A global medical devices company in Caesarea is looking for a Quality Management System (QMS) team member.
    * Develop equipment and software validations per ISO 13485/FDA 21 CFR part 820.
    * Generate and review completeness of documents such as: drawings, SOPs, equipment and software validation protocols and reports.
    * May perform or lead QMS or Design Assurance activities (e.g., document control, audits, receiving inspection, non-conforming product, ECO).
    Requirements:
    * B.Sc. in Mechanical/Electrical/Biomedical Engineering, or equivalent - a must.
    * Minimum of 3-year experience in medical device field or Software QA or equivalent - a must.
    * Quality Management System experience - a must.
    * Cardiovascular medical device experience.
    * Former employee of a large international company / Interactions with business units in US and Europe.
    * Experience in supplier and internal audits.
    * Experience in Clean Room validation.
    * Willingness to travel abroad up to twice in a year.
    * Proficient in English and technical writing.
     
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    5860977
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    עדכון קורות החיים
    לפני שליחה
    Location: More than one
    Job Type: Full Time
    Application specialist R&D for international company.
    Position Responsibilities:
    User's controlled documents: Create user's manual, quick start manual, application & clinical related documentation.
    Field support: Field issues diagnostic, Field issues diagnostic, Onsite and remote costumer support, Onsite training.
    Clinical Study support: Assistance for IRB and ethics committee submissions, Assistance for clinical study related administrative tasks, Onsite training, and support.
    Define usability plan document for technologists and physicians.
    Implement usability plan and create report for regulatory approvals.
    Requirements:
    Medical background.
    At least 3 years experience in medical imaging devices (SPECT, PET, CT).
    Experience in managing clinical studies.
    Experience in CT field - added value.
    Good English writing and speaking.
     
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    5859849
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    עדכון קורות החיים
    לפני שליחה

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