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Senior Quality Engineer

Company: Veterans Prime, Inc.
Location: Germantown
Posted on: March 19, 2023

Job Description:

We are looking for a Senior Quality Engineer located in Germantown, WI. The Senior Quality Engineer will monitor and continuously improve upon the Quality System Elements.
A qualified candidate would fulfill these requirements:

  • Bachelor's degree in a science/engineering related field and seven to ten years of experience, or combination of accrued on-the-job experience and training.
  • QS / ISO System experience.
  • Understanding/working knowledge of ISO13485, ISO 16949 and FDA 21 CFR Part 820 and 11.
  • Previous auditing experience is preferred.
  • Experience with ISO class 8 cleanroom is desirable.

    Below are the essential duties and responsibilities:

    • Perform batch record review to release products.
    • Develop, review and approve validation protocols and final reports. Analyze the validation data. Assist in deviation resolution and corrective actions.
    • Facilitate audit finding and complaint investigation meeting.
    • Review and approve complaint, CAR and exception report.
    • Act as a liaison between customer and company.
    • Act as subject matter experts on quality system processes.
    • Assist in development of control plan, PFMEA, visual criteria, manufacturing work instruction, incoming inspection plan and in process inspection report for new products.
    • Provide disposition of nonconforming products.
    • Review and approve engineering change package.
    • Update manufacturing related procedures and quality system procedures to address gaps.
    • Mentor QEs in their daily tasks.
    • Continuously improve the quality system.
    • Acts as backup for the quality manager during 2nd and 3rd party audits.
    • Perform internal audit.
    • Other duties as assigned.

Keywords: Veterans Prime, Inc., Milwaukee , Senior Quality Engineer, Engineering , Germantown, Wisconsin

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