Senior Quality Engineer

Job Locations US-WI-Germantown
ID
2016-1082
Category
Engineering

Overview

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.

Qualifications

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.

Responsibilities

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.

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