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    QA Senior Manager - Yongin-si, 대한민국. - Abbott

    Abbott
    Abbott Yongin-si, 대한민국.

    1주 전

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    설명

    MAIN RESPONSIBILITIES
    ᆞEnsure a Quality system is in place in compliance with Regulatory and ISO standards
    ᆞLead QA organization (HC 20~30) to implement compliance, supplier quality, design quality, change control and internal audit, Post market surveillance
    ᆞExpertise in ISO, GMP international standards
    ᆞMake release decisions of finished products
    ᆞLead Quality Management Remediation Project to meet Abbott quality standards


    QUALIFICATIONS
    ᆞOver bachelor degree in relevant major (Knowledge on diagnosis mechanism (Biological, Immunization)
    ᆞLeadership experience in quality systems (> 10 years) in Pharmaceutical , medical device or IVD
    ᆞExperience in leadership role in organization more than 10 HC
    ᆞExperience in IVD with understaing of ISO , EU 2017/746(IVDR) and other rapid diagnostic device related international requirement
    ᆞExcellent communication skill in English (in technical writing and conversation)
    ᆞExceptional communication skills and ability to facilitate cross-functional cooperation
    ᆞPreferred employment in global, international IVD, pharmaceutical firms(> 5 years)

    Experience/Background
    Experience Experience Details
    Minimum 15 years


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