Ivoclar Vivadent Inc.

  • Quality Engineer, Non-Conformity Management

    Job Location US-NJ-Somerset
    Posted Date 2 weeks ago(6/5/2018 10:03 AM)
    ID
    2018-1383
    Department
    Quality Assurance
    Type
    Regular Full-Time
  • Overview

    We offer an excellent opportunity for a Quality Engineer, Non-Conformity Management to plan, coordinate and execute various aspects of the Quality Management System to ensure quality production of products consistent with established standards, and to drive continual improvement. Coordinates and documents the investigation of non-conforming materials. Monitors, coordinates and documents various activities related to customer complaint investigations.

     

    Ivoclar Vivadent Manufacturing, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EOE/AA. Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet. 

    Responsibilities

    • Work with QA/RA Director in maintaining Quality Systems policies and procedures to ensure regulatory compliance by following FDA QSR and ISO requirements.
    • Manages and facilitates non-conforming material reporting and analysis system. Responsible for participating in resolution of quality issues within the manufacturing plant and collaborating with internal and external manufacturing and engineering departments to implement quality improvement projects as assigned. Generates reports and provides analysis on trends on a bi-monthly basis. Provides training to individuals in the QIM system as defined.
    • Manages customer complaint systems including coordination of investigations and review of root cause analysis. Documents activities in the shared CRM system. Generates reports and completes data analysis and trending using the shared system data.
    • Participate and lead internal audits as a member of the facility internal audit team.
    • Gather, analyze and distribute data from various quality system elements as assigned. Provide trending and analysis of quality related metrics. Apply mathematical/statistical concepts to understand and interpret data for trend analysis.
    • Understand and support various systems used in Quality Systems such as QUMAS for document management and IDA for specification management.
    • Create or update QS procedures. Maintain procedures relevant to scope of job description.
    • May participate in Third Party audits as support to QA/RA Director.
    • Provide support for continuous improvement of the Quality Management Systems.
    • Perform other related duties and assignments as required.

     

    Qualifications

    • Bachelor’s degree in the sciences or in engineering preferred. Work experience in ISO13485 or ISO9001 regulated establishment.
    • Familiarity with interpreting regulations and quality systems. Working knowledge of FDA QSR, ISO13485 or ISO9001 standards preferred.
    • Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction, and make decisions with confidence.
    • Exceptional organizational skills and ability to plan and implement resolutions to technical problems.
    • Ability to effectively manage time to meet assigned deadlines, prioritize multiple work assignments, and adapt to change.
    • High degree of initiative and self-motivation with a strong sense of accountability.
    • Good interpersonal and communication skills, both written and oral.
    • Computer literate in Microsoft Word, Excel, Access, and Project. Working knowledge of Windows.
    • SAP knowledge helpful.
    • QUMAS knowledge helpful.

    Physical Demands

    Ability to sit or stand for up to 8 hours per day, view computer monitor and move about between departments and buildings to effectively fulfill the essential functions of the job.

     

    Equipment & Machinery Used

    Desktop or lap top computer.

     

    Ivoclar Vivadent Manufacturing, Inc. offers competitive compensation, opportunity for training and advancement, medical and dental benefits, other voluntary benefit options, life and disability insurance, competitive time off program, 401(k) and pension plan, flexible spending accounts, corporate wellness programs, on-site fitness room, and a positive, up-beat work environment!

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