Integra LifeSciences

  • Senior QE Engineer

    Vacancy ID
    2017-25420
    Location
    CH-NE-Le Locle
    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 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

    Responsibilities

    • Quality support for production and for various projects
    • Plan, coordinate and direct the quality aspects of process validation
    • Write validation documentation (protocols, reports, process specifications, work instructions, pFMEA, master validation plan)
    • Provide projects updates and presentations
    • Review and approve changes to documentation and processes
    • Apply and enforce GMP
    • Non-conformance management (initiation / evaluation / disposition on the batches / investigation)
    • Quality control technical support
    • Participation in development and updating of procedures and other quality documents
    • Participation in validations of new processes (Processes, products, methods & software)
    • Validation of different integrated processes of Integra LifeSciences & Codman Neurosurgery

    Qualifications

    • Minimum of 2 years’ experience in Quality Engineering area (Medical device or pharma industry experience highly preferable)
    • Engineering degree or equivalent
    • Knowledge in statistic ( capability, gage RR, Anova test, control chart)
    • Quality knowledge in the medical industry
    • Organized and methodical
    • Outstanding communication skills with outgoing and proactive attitude
    • Solid organizational skills
    • Team spirit
    • Fluent in French and English
    • Ability to work with cross functional team (R&D, RA, manufacturing engineering, planning, production)
    • Proactive, rigorous, autonomous

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