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    Quality Engineer - Hermann, United States - Spectrum Plastics Master

    Spectrum Plastics Master
    Spectrum Plastics Master Hermann, United States

    4 weeks ago

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    Description
    Job Details

    Level
    Entry

    Job Location
    Laser Light - Hermann - Hermann, MO

    Position Type
    Full Time

    Education Level
    4 Year Degree

    Job Shift
    Day

    Job Category
    Engineering

    Description

    ESSENTIAL DUTIES AND RESPONSIBILITIES
    • Ensure that the organization's Quality management System conforms to customer, internal, ISO 9001:2015, ISO 13485:2016 and regulatory/legal requirements.
    • Be the technical expert in the Electronic Quality Management System and modules that control relevant functions
    • Oversee process and product inspections that include deciding and implementing inspection methods, sampling plan and inspection equipment
    • Assist to quality meetings and management review meetings to report to top management technical data regarding the performance and effectiveness of the quality management system
    • Work with engineering and quality manager and lead quality/continuous improvement projects
    • Work closely with the customer and developing quality assurance plans for new customers and improving process efficiency for existing customers.
    • Provide support in entering of RMAs, CAPA, monitoring of DCRs and Deviations, and PPM tracking.
    • Assist in document control functions by creating new operating procedure, work instructions, forms etc.
    • Responsible for supporting Engineering and Manufacturing to resolve technical issues and implement corrective and preventive action (CAPA)
    • Maintain KPI's as required by Quality Management System
    • Leading supplier / internal process improvement projects in an effort to increase the supplier/internal process capability of consistently meeting ISO and regulatory requirements. Projects may include: process analysis, value stream mapping, process capability and throughput analysis, DOE, 6-Sigma, 5S and Kaizen events
    • Act as the Supplier Quality Representative and conduct all Supplier Quality Reviews.
    • Programming CMMs and other measurement gages to customer drawings
    • Assist maintenance department with external and internal calibration of critical measuring equipment
    • Manage, coordinate and assist teams for internal and external validation/verification of processes
    • Assist in audits which includes ISO 9001:2015, 13485:2016 Internal, External, supplier and Customer audits
    • Collaborate with external interested parties to improve Quality management system
    • Other duties as assigned
    Qualifications

    EDUCATION and EXPERIENCE
    • Bachelors' degree or higher in Engineering Management/Mechanical/Manufacturing/Industrial Engineering or related field with 2+ years' experience
    • 2 years in Quality Engineering or related field in the industry preferred
    • Prior experience and ability to read blueprint and drawings
    KNOWLEDGE, SKILLS, AND ABILITIES
    • Lean Six sigma Green Belt certification or higher desired
    • Knowledge of GD&T and ISO 9001:2015, ISO 13495:2016 standards
    • Proficiency in precision measurement tools like Vision systems, 3D profilometers, optical microscopes etc.
    • Experience working in ISO Class 5 and Class 6 cleanroom environment
    • Knowledgeable of Control Plans, DOE, XFMEA, SPC, and other lean six sigma tools
    • Excellent verbal, technical writing, interpersonal and organizational skills required


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