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We are searching for a Quality Engineer with CAPA experience for a global quality consulting company. The Quality Engineer – CAPA will work with one of the world’s medical device leaders running complaints investigations.
Requirements fo the Quality Engineer – CAPA
  • Bachelor’s degree in engineering, preferably mechanical engineering
  • CAPA experience in a manufacturing facility.
  • 2+ years’ experience in a production manufacturing environment.
  • Experience: RCCA, 8D, DMAIC, PDCA, SPC, GD&T, ISO9001 or ISO 13485 or IATF16969 or AS9100
  • Ability to read and interpret engineering drawings, product specifications and industry standards.
  • Mechanical inspection experience using various inspection metrology.
  • Knowledge of GD&T and ISO standards and/or similar regulations.
  • The ability to travel domestically and internationally approximately 20%.
  • Experience with a variety of component manufacturing, production and qualification test processes related to machining, welding casting, molding, stamping, forging, painting, plating, heat treating, assembly and fabrication preferred.
  • Lean SS Black Belt certification or ASQ CQE preferred
  • Mechanical aptitude for working with tools to perform assembly and testing preferred
Responsibilities of the Quality Engineer – CAPA – Medical Devices
  • Lead CAPA – corrective action – initiatives in all areas of the quality, manufacturing and warehouse functions.
  • Identify, investigate, and reports deficiencies and causes related to supplier problems and customer complaints.
  • Monitor the effectiveness of the improvement process.
  • Provide periodic progress reports of the CAPA, complaint and continuous improvement activity.
  • Responsible for the quality aspect of the supplier performance dashboard and initiates improvement activity based on indicators identified in the quarterly reports.
  • Evaluate and monitor supplier performance to determine actions required for improvement.
  • Provide support to the internal audit function to assure quality problems are addressed and eliminated.
Application Instructions: Please apply using the form or send your resume to Debbie Winkelbauer.