Sr. Quality Engineer

Company: Integra Life Sciences ( Learn More )

General Information
US-NJ-Plainsboro Township
N/A
4 Year Degree
Full-Time
Not Specified
Not Specified
False
False
Job Description 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, spine surgery, and reconstructive and general surgery.

Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound 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. 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 3,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol 'IART.'

Responsibilities:
  • Assures Regulatory and Quality compliance in the area of verification and validation, design controls, and design transfer engineering for Integra’s biomaterial products.
  • Contributes to and executes engineering schedules and plans.
  • Supports new product launches in compliance with EMA, FDA, and Notified Body requirements
  • Reviews and approves written reports and engineering documentation as necessary.
  • Executes tactical implementation of strategic plans.
  • Assures compliance with company Standard Operating Procedures and policies.
  • Demonstrates knowledge and understanding of Good Manufacturing Practices and all other applicable standards.
  • Reviews and approves engineering test protocols for testing of component parts and integrated systems.
  • Prepares verbal presentations for various company meetings.
  • Job Requirements
    • Bachelor’s Degree in Engineering or other scientific discipline. Master’s degree preferred.
    • Ten (10) years’ experience in engineering practice including project development, Quality, Regulatory Affairs or manufacturing responsibility.
    • Demonstrated experience with European Medicines Agency (EMA) regulation, specifically Annex 1 requirements.
    • Demonstrated experience in a FDA controlled environment (Medical Device, Biotech, and Drug/Medicinal).
    • Demonstrated experience with Design Control / Change Control.
    • Demonstrated experience with Risk Management Practices
    • Demonstrate technical leadership among peers.
    • Knowledge of engineering documentation.
    • Knowledge of engineering test protocols.
    • Knowledge of design transfer concepts
    • Skills in personal computer spreadsheet, word processor and engineering tools.
    • Ability to carry out engineering calculations and analysis.
    • Ability to review engineering documents, test protocols, laboratory notebook entries and reports.
    • Ability to present verbal reports at company meetings.
    • Ability to review and analyze engineering reports.
    • Ability to participate and represent the Quality function on design / transfer teams
    • Knowledge and understanding of Good Manufacturing Practices and other applicable standards.

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