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Quality Assurance Manager

Location

Kiel, WI

Job Summary

We are seeking an individual for the position of Quality Assurance Manager in Kiel. Under the direction of the Vice President of Operations, the Quality Assurance Manager coordinates, implements, and manages the quality assurance function to the requirements of current ISO, FDA, and ASME Standards.

Key Responsibilities

  • Point person for audits (internal, customer, supplier, certification, regulatory and third party QA systems)
  • Process validation definition and execution
  • Development and execution of corrective actions
  • PPAP preparation, submission and approvals
  • Quality Alerts, CAR, CCR, SCAR and NCMR processes for purchased and manufactured goods.
  • Approval and maintenance of controlled documents.
  • ECR approval
  • Determination of customer credit and disposition of returns
  • Data analysis and process improvements for variation reduction, scrap, PPM, NCMR, rework
  • Initiation and approval of deviations
  • Execution of scorecards and KPI's
  • Supervision of QA techs
  • External customer visits and communication
  • Supplier interface for component and subcontract
  • Continuous improvement - variation reduction, scrap reduction
  • Risk assessment/risk analysis
  • Assigning QA Hold in the warehouse
  • Management review

 

Qualifications

  • 4 year degree in Engineering, Quality, Manufacturing, or Operations Management required (Master’s degree preferred)
  • 10+ years of experience in related field
  • ASQ, CQM/OE certification preferred
  • Black belt in Lean Manufacturing Six Sigma preferred.

 

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