Integra LifeSciences

  • QA Specialist

    Vacancy ID
    2018-26387
    Location
    JP-Tokyo
    Position Type
    Regular Full-Time
    Category
    Quality Assurance
  • Overview

    QA Specialist will be responsible with below 3 area working closely with QA Manager.  

    • Quality System Management
    • Product Release and Distribution
    • Other related role

    *This position is based in Tokyo, Japan, and requires native or near native level of Japanese language skill and a proper working visa.

    Responsibilities

    Quality System Management

    • Prepare/revise/control SOPs and forms to ensure compliance with Japan QMS requirements.
    • Act as document controller to manage QMS documents
    • Educate and train QMS for Integra Japan staff
    • Gain and maintain ISO13485 certificate.
    • QMS audit for both internal and external

    Product Release and Distribution

    • Perform in-coming QC and release Integra products in compliance with PMD Act
    • Manage labeling for products in compliance with PMD Act
    • Manage foreign manufacturers (FMR, Quality agreement, Periodic confirmation)
    • Resolution of quality issue and CAPA
    • Manage product recall

    Others

    • Support QMS Application for Japanese distributor
    • POLO Supplier approvals and management
    • Local supplier audits as required by division/corporate

    Qualifications

    Education and Experience

    • Bachelor's degree
    • Degree in pharmacy or scientific field
    • Minimum 5-8 year QA experience in Pharmaceutical / Medical Device (Class IV) Industries

     

    Essential Skills and Abilities

    • Excellent verbal and written communication skills
    • Ability to multiple tasks, prioritize and work under pressure
    • Strong negotiation skills with Japan authorities (MHLW, PMDA, TMG, Notified body)
    • Good organization skills and ability

     

    Competencies

    • Business level English
    • Computer skills – MS-Word, Excel, PowerPoint

    Options

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