• Salt Lake City, UT, USA
  • doe
  • Full Time

Biosonix is an ultrasonic and electronic medical device engineering and manufacturing company with ISO 13485:2016 certification.  We design and manufacture to 21 CFR 820 (GMP). We have an opening for a quality engineer/quality manager.  Responsibilities include maintaining the QMS to ensure ISO and customer quality agreement compliance; hosting ISO and customer audits and conducting internal audits; reviewing engineering documents such as verifications; conducting Management Review meetings per the QMS and ISO requirements; conducting DHF reviews; overseeing Document Control; overseeing quality inspection activities; and other related tasks as needed.

Experience with Quality Management Systems, ISO standards, and FDA regulations is required.

Experience in Data Analysis, Failure Analysis and Statistics is desired.

Salary commensurate with experience.




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