Principal Quality Engineer

A medical device company located in the Chicago-land area, is looking for a Principal Quality Engineer to develop and implement prevention based methodologies used in design, manufacturing, testing, sustainability and correction of products and services

This opportunity gives a candidate the ability to be in a strategic cross functional role and be a part of an organisation that is creating an innovative and cutting-edge product line.

Among others, this Principal Quality Engineer would be responsible for:

  • Understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
  • Applying problem solving and quality improvement tools and techniques, including, preventative and corrective actions.
  • Developing and implementing quality programs, including tracking, analyzing, reporting and problem solving.
  • Acquiring and analyzing data using appropriate standard quantitative methods to facilitate process analysis and improvements.

The most ideal candidate for this Principal Quality Engineer role will have the following qualifications:

  • Bachelor's in Engineering with 5 years medical device experience, or Masters in Engineering with 3 years of medical device experience
  • Experience with design control under FDA regulations and GMP (21CFR820) and ISO 13485 standards.
  • Statistical knowledge of sampling plans and control charts; internal and external audit experience; and ASQ Certification such as CQE, CMQ/QE, or CQA/CBA.

If you would be interested in exploring this exciting opportunity, please apply directly with an attached resume and the best time to reach you.

Sthree US is acting as an Employment Agency in relation to this vacancy.