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Cincinnati, OH Full Time Posted: Wednesday, 11 December 2019
Quality Engineer - Medical Devices

Global medical devices company seeks a Quality Engineer to lead quality activities both at the Cincinnati site and at supplier locations. The Quality Engineer will oversee manufacturing quality activities. The Quality Engineer will:

  • Process and monitor non-conforming components (NCRs).
  • Provide failure analysis of product, components, and or systems for identification of root cause and corrective and preventive actions.
  • Perform internal quality system audits to assure compliance with domestic and international regulations and requirements.
  • Develop, implement, and or review procedures and work instruction to ensure compliance to regulatory and or quality requirements.
  • Perform review of Technical Files, Device History Files, and design changes.
  • Run CAPAs
  • Coordinate and participate in non-conforming investigations and applies sound problem-solving methodologies.

Requirements for Quality Engineer:

  • Bachelor's degree in a scientific or technical discipline, ie engineering
  • 3+ years relevant experience in medical device OR another highly regulated industry such as automotive, aerospace or microelectronics. Pharmaceutical candidates are not a fit.
  • Experience with electromechanical products preferred
  • Lean Six Sigma training, certification preferred
  • ASQ quality certifications preferred ie CQA, CQE
  • Strong analytical and statistical skills
  • Exceptional communication skills, oral written and electronic
  • The ability to manage multiple competing priorities under tight timelines.,
  • Working knowledge of Microsoft Office Suite, Microsoft Word, Excel, PowerPoint, Visio, etc.
  • Working knowledge of Quality System regulation (QSR/FDA regulation), and ISO13485 standards

Cincinnati, OH, United States of America
Job Juncture
Click apply
12/11/2019 5:12:27 PM

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