Integra LifeSciences

  • Quality Engineer (Change Control)

    Vacancy ID
    2018-26649
    Location
    US-NJ-Plainsboro
    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 4,400 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

     

    It's a great time to join our growing company and become one of our impassioned colleagues making lives better for the patients we serve!

    Responsibilities

     

    • Ensure change control compliance to regulations as well as internal policies and procedures.
    • Responsible for the supporting the maintenance of the change control system
    • Responsible for reviewing change control documents and deliverables
    • Capable of communicating and coordinating with internal and external functional areas to ensure accurate, complete and efficient change control processing
    • Ensures that impacted sites or partners are appropriately notified of changes affecting their sites
    • Have familiarity with process validation, knowledge of ISO 13485 and CFR 820 Medical Device regulations
    • Liaison with Regulatory Affairs to understand potential filing impact of changes being requested
    • Review and assist in resolution of documentation issues as they relate to change controls
    • Act as a point of contact for change control requests and managing priorities
    • Review all electronic documents submitted to change control for correct formatting, spelling and clarity of text before obtaining approval
    • Responsible for scheduling, facilitating and managing Change Control Review Board (CCRB) meetings. May also lead meetings as required
    • Tracking, follow-up and implementation of change control records
    • Perform other document management /change control related activities as required
    • Tracking and trending of data for management review

    Qualifications

     

    • Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology)
    • Minimum of 2 years’ experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries.
    • Familiarity with FDA regulations and ISO series of quality standards preferred
    • Demonstrates solid organizational, communication, document and project management skills
    • Proficient with the MS Office Suite
    • Must be able to work independently with minimal supervision
    • Able to prioritize work to meet organizational goals and objectives
    • Capable of both written and verbal effective communication skills
    • Proficient in Oracle R12/Agile preferred

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