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Quality Assurance Specialist Engineer

Boston, MA

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Our client is seeking a Quality Engineer for Manufacturing Quality Assurance!

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:

  • Support Quality Control, R&D, and Manufacturing with product and process validation work
  • Manage and improve assigned areas within QMS, apply statistical techniques and lead the product & process
  • Develop testing methods and devise sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data
  • Provide support during QMS audits and implement new regulatory audits within the QMS
  • Prepare reports to communicate results of technical activities & prepare and present technical and program information to team members and management
  • Communicate significant issues or developments identified during quality activities and provides recommended process improvements to management
  • Perform review and evaluation of supplier quality information in order to qualify vendors, including completing supplier audits

Qualifications:

  • Bachelor’s degree in physics, biology, chemistry, chemical engineering, mechanical engineering, or biomedical engineering
  • 5-10 years of relevant experience in the medical device industry