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Senior Quality Engineer

Boston, MA

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Our client is seeking a Quality Engineer near Boston, MA!

Our client is a medical device company that is rapidly expanding with a recent new acquisition and multiple medical devices on the market in varying therapeutic areas. This company has been changing the way medical devices are used since 1983.

Specific Responsibilities:

  • Take care of day-to-day activities based on goals in accordance with corporate policies and goals that come with building high-quality medical devices
  • Evaluate medical device failures, product complaints, and write summary reports
  • Determine root cause and implement Corrective and Preventative Actions
  • Evaluate risks in product design and the manufacturing process of medical devices
  • Update the quality system based on non-conformities found during internal and external audits
  • Review all non-conforming material reports for planning and disposition
  • Evaluate supplier performance which is based on data collected at incoming inspection

Qualifications:

  • Bachelor’s degree in either biology, biotechnology, or biomedical engineering
  • 2+ years of experience in the medical device industry
  • Understanding of ISO13485, ISO10993, & ISO14971
  • Experience with Microsoft Word, Excel, PowerPoint, and Outlook
  • Must have strong oral and written communication skills