Integra LifeSciences

  • Quality Assurance Engineer

    Vacancy ID
    2018-27925
    Location
    US-OH-Cincinnati
    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

    • Escalate and/or present CAPA program to Site or Corporate Management.
    • Active participation during Notified body audits or FDA Inspections.
    • Lead and participate with Customer Complaint Investigation processes.
    • Support Manufacturing and Project Teams by developing DOEs, FMEAs, statistically sound tests, and process controls for appropriate support of results.
    • Develop statistically valid sampling plans for QC and validation activities.
    • Support improvement/investigation efforts at the base business level, working hand to hand with Manufacturing Engineers and Machinists.
    • Leads and participates in activities related to non-conformances (MRB), Corrective & Preventative Actions (CAPA support), and complaints.
    • Document Change Order support. Initiate or approve change packages, ensuring process is implemented properly and QA issues have been addressed.
    • Work with Product Development team in order to ensure all aspects of Design Transfer activities are being met. Formulate product quality plans based on results of risk analysis.
    • Internal Audit Program participation. Work with the established audit plan to complete audits and prepare audit reports.
    • Actively participate in the Supplier Management program. Audit the quality system of new and existing suppliers and prepare audit reports including recommendations. Act as the Technical Specialist in supplier-related quality issues. Oversee supplier corrective actions when appropriate.
    • Write and coordinate efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR compliance
    • Identify and implement opportunities for continuous improvement.
    • Knowledge on Risk Management tools as per ISO14971: 2012.

     

    Qualifications

    Education:

    • Bachelors Degree in a scientific or technical discipline, Master’s degree preferred.

     

    Experience:

    • Minimum of 3-5 years experience in a Quality Assurance role for manufacturing
    • Regulated environment/industry experience is required.
    • Experience on High Precision machining process is highly desired.
    • ASQ Certification as a CQE or CQA desired.
    • Auditing experience highly preferred
    • Six Sigma (Green Belt or Black Belt) preferred

     

    Skills & Abilities:

    • Strong skills in technical writing.
    • Strong Statistical and Risk Management applicability skills
    • Strong interpersonal, organizational, and communication skills and respect for confidentiality.
    • Demonstrates knowledge of statistical sampling and analysis, including DOE design.
    • Must be able to observe company policies and safety procedures at all times.
    • Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.
    • Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.

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