Integra LifeSciences

  • QA Manager

    Vacancy ID
    2018-26295
    Location
    JP-Tokyo
    Position Type
    Regular Full-Time
    Category
    Quality Assurance
  • Overview

    Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

     

    Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery.  In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.


    Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

    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.

    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 product recall

    Others

    • Support QMS Application for Japanese distributor
    • Manage FMR

    Qualifications

    Qualifications

    • QA Manager regulated in PMD Act

     

    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
    • Native level Japanese
    • Computer skills – MS-Word, Excel, PowerPoint

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