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Senior Quality Engineer

Company: Kamdon solutions
Location: Grafton
Posted on: February 23, 2021

Job Description:

Company Overview
Microbrush International develops, produces, and markets innovative disposable applicators designed for the placement of controlled amounts of materials in hard-to-reach areas. Microbrush is a wholly owned subsidiary of Young Innovations, Inc. Young Innovations is a manufacturer and marketer of high quality dental equipment. Role Overview
Microbrush is looking for a dynamic, focused, and engaging leader to join our team as the Senior Quality Engineer at our facility in Grafton, Wisconsin. The Senior Quality Engineer will provide support to the manufacturing process within a team oriented, customer-driven organization. This position will provide quality support to the facility relating to corrective actions, process control, statistical analysis, process and test method validation, and continuous improvement.
Responsibilities

  • Lead the generation, execution, and review of qualification/validation protocols and reports.
  • Lead the planning, implementation, and effectiveness verification of corrective and preventive actions.
  • Assist production with the investigation of component and finished good non-conformances.
  • Assist supplier management and Quality Control with the investigation of sourced raw materials, components, and finished goods.
  • Monitor and investigate deviations from Quality System processes.
  • Review continuous improvement of quality systems, procedures, & executed records to determine gaps and to identify areas for improvement.
  • Review proposed technical changes and identify related impact to processes/procedures/ materials etc.
  • Generate and maintain specifications for raw materials, components, & finished product.
  • Perform risk assessments (FMEA, etc.) and initiate action plans.
  • Assist the QA Manager with gathering and analyzing data to determine performance of Quality and Operations (metrics).
  • Oversee the site calibration program. Qualifications
    • Bachelor of Science Degree in engineering or science.
    • ASQ Certified Quality Engineer or Six Sigma Black Belt Certification desired.
    • Seven years of quality or engineering experience in an FDA regulated environment.
    • Three years process validation experience (IQ, OQ, PQ), test method validation experience and maintenance of master validation plans.
    • Three years experience in sterile packaging and ETO sterilization desired.
    • Experience within a high-volume manufacturing facility strongly preferred
    • Excellent verbal and written communication skills.
    • Ability to organize, prioritizes, and perform multiple tasks with minimal supervision
    • A sense of urgency, good attention to detail, and follow-thru.
    • Working knowledge of Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. Microbrush/Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer Young Innovations is an equal opportunity employer and recruits, hires, trains and promotes persons in all job titles without regard to race, color, religion, sex, national origin, age, citizenship, disability or veteran status.

Keywords: Kamdon solutions, Worcester , Senior Quality Engineer, Engineering , Grafton, Massachusetts

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