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Quality Engineer

Domaille Engineering
    Published
    May 10, 2022
    Location
    7100 Dresser Drive NE, Rochester, MN
    Category
    Job Type

    Description

    Core Responsibilities:

    • Design quality plans to assure regulatory, customer, and product requirements are being met (i.e.: inspection sheets, sampling plans, gaging, and/or work instructions as needed).
    • Development of supplier quality plans with the assistance of purchasing to make sure regulatory, customer, and product requirements are being met.
    • Lead/Assist product and/or process verification or validation studies.
    • Develop risk analysis plans (FMEA and/or ISO 17025) to mitigate product/process risk.
    • Lead/Assist projects associated with continual improvement of the organization’s Quality Management System, manufacturing, and product processes.
    • Assist in the maintenance of the Quality Management System
      • Document Control
      • Internal Auditing
      • Corrective/Preventive Actions
      • Control of nonconforming product
      • Control of monitoring and measuring devices (calibration)
    • Assist the Quality Manager with the maintenance of the calibration system.
    • Train the employees throughout the organization on the proper care and use of inspection equipment.

    Critical Elements:      

    • Have the ability to interpret and apply ASME Y14.5 Geometric Dimensioning and Tolerance (GD&T).
    • Understands and is able it implement sampling plans.
    • Has the ability to use statistical tools to identify and communicate product/process variation throughout the organization.
    • Understands the use of the seven basic quality tools to lead/assist with continuous improvement throughout the organization.
    • Able to analyze product/process risks, document those risks and identify ways to mitigate those risks (i.e.:  FMEA or other applicable methods).
    • Provide effective leadership throughout the organization.
    • Good working knowledge of a Quality Management System (i.e.:  ISO 9001 or 13485, AS9100, and etc…).
    • Able to interpret and deploy regulatory/customer requirement throughout the organization (FDA, ASME, ANSI, MIL, and etc…).
    • Able to plan and effectively lead an internal audit.
    • Communicates involvement and results of quality assurance activities (i.e.:  FMEA, process improvements, offline experimentation, reliability/durability product testing, and etc…) throughout the organization.
    • Effectively oversee the metrology system
      • Sets up equipment to test, evaluate, and calibrate other instruments and test equipment.
      • Plans sequence of testing and calibration procedures for instruments and equipment.
      • Disassembles instruments and equipment and inspects components for defects.
      • Measures equipment parts for conformity with specifications.
      • Devises formulas to solve problems in measurements and calibrations (Gage R & R).
      • Will align, repair, replace and balance component parts.
      • Reassembles and calibrates instruments and equipment.
    • Represents quality in the handling of quotes.

    Education/Experience:  Graduate of two-year vocational school program or two years related work experience and/or training; or equivalent combination of education and experience.

    Skills:  Mechanical aptitude, detail oriented.  Able to read, analyze, and interpret regulatory, scientific and technical standards/requirements.  Has the ability to communicate quality requirements to suppliers, customers, and employees.  Good problem solving skills (root cause analysis).  Working knowledge of Microsoft Office and quality management software, needed to enhance productivity and quality of work.

    Training:  OSHA Right to Know, Quality Management System orientation, Geometric Dimensioning and Tolerance, Leadership, Metrology, Sampling Plans, Seven Basic Quality Tools, Risk Analysis, Leadership, Communication, and Auditing.

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