Integra LifeSciences

  • Sr Engineer, Quality Assurance

    Vacancy ID
    2018-25797
    Location
    US-PA-York
    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

    Sr. Quality Engineer will provide Quality and Compliance related support for the manufacture and distribution of medical devices in accordance with applicable Quality Management regulations (ISO 13485, 21 CFR 820, etc.)

    • Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards
    • Participate in FDA inspections, ISO Certification, surveillance audits and customer audits
    • Interact and coordinate activities with other departments, external vendors and customers
    • Assist or lead in the identification and implementation of CAPA
    • Plans and conducts the analysis, inspection, design, test, and/or integration of material and parts to assure the quality of assigned product or component.
    • Aid in the implementation of SPC control systems with Manufacturing and Quality Control. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
    • Develops new approaches to solve problems identified during quality assurance activities. Communicates significant issues or developments identified and provides recommended process improvements to management.
    • Prepares and presents technical and program information to team members and management.
    • Identify statistically based sampling plans and training for Inspection.
    • Support new product development and validations for new and existing products, processes and equipment.
    • Completes internal quality system audits
    • Collection and reporting of metrics and data as required
    • Facilitate the execution of Risk Management activities.
    • Performs other Quality System related duties as required.
    • Gives and welcomes constructive feedback; contributes to building a positive team spirit.
    • Treats others with respect; works with integrity and ethically; upholds organizational values.

     

     

    Qualifications

    The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

     

    Education:

    • Bachelor’s degree in Engineering (Biomedical, Mechanical, or Electrical)
    • Certifications: ASQ Certification as a Quality Engineer, Quality Improvement Associate, Quality Process Analyst, or Quality Technician strongly preferred.

     

    Experience:

    • 3 to 5 years of experience in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing. Accredited Lead/Biomedical Auditor certification preferred.
    • Knowledge of IEC 60601 electrical safety standards and RoHS and WEEE regulations preferred.
    • Lean/Six Sigma certification preferred.
    • Strong project management skills required.
    • Demonstrated knowledge of statistical sampling and analysis.
    • Demonstrated excellent organizational, writing and verbal communication skills
    • Proficient with the MS Office Suite, including Microsoft Visio and Project.
    • Experience working in Oracle, Agile and TrackWise systems preferred

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