Integra LifeSciences

  • Quality Engineer

    Vacancy ID
    2018-27430
    Location
    US-TN-Memphis
    Position Type
    Regular Full-Time
    Category
    Engineering
  • 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

    • Execute site, process, and product improvements
    • Partner with Operations and Manufacturing Engineering for facility maintenance and upgrades
    • Provide quality oversight on equipment calibrations and preventative maintenance activities
    • Lead software integration activities within site with support from Corporate office
    • Work directly with suppliers for quality compliance activities
    • Support design transfer projects with support from Product Development team
    • Draft and provide guidance on site SOPs for equipment, processes, and quality system elements
    • Draft or provide guidance on technical documents within manufacturing processes
    • Uphold regulatory guidelines set forth by the FDA, AATB, HHS, and OSHA
    • Participate in site regulatory audits

    Qualifications

    • Bachelor’s degree required with a focus in engineering
    • Minimum 5 years of experience working within an FDA regulated industry (e.g., Medical Device, Pharmaceutical, HCT/P).
    • Understanding of 21 CFR 820 and/or 1271, ISO 13485, AATB Standards, and ISO 14971 preferred.
    • Self-motivator with an ability to work with minimal supervision. 
    • Strong communication and interpersonal skills. 
    • Must have experience working in MS Office Software Suite and Minitab.
    • ERP/MRP management software experience is preferred..      

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