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POSTED 08/03/2021

Quality Engineer

Location: Roseville, MN
Currently looking for a skilled individual to fill a Direct Hire Quality Engineer opening with a company located in Roseville, MN. Interested candidates should have a bachelor’s degree plus 5 years of quality experience, with methodical problem-solving skills.


Quality Engineer Job Description:
  • Review and approve Process Travelers, Incoming inspections, and calibration reports.
  • Training QC Inspectors on incoming inspections and In-process inspections.
  • Create quality standards for all in-process inspections to be used for training. 
  • Provide input to manufacturing documentation including inspection procedures, and manufacturing procedures, to ensure that the resulting products are consistently manufactured and tested.
  • Review process improvements to ensure no new risks are introduced to the product and improvements are adequately tested and implemented to meet existing product specifications and quality standards.
  • Update risk management document to reflect quality improvements with process improvements implemented. 
  • Conduct internal audits as assigned
  • Perform review of product scrap trend charts and perform trending and/or analysis of Supplier nonconformances
  • Identify opportunities for improvement utilizing Internal Auditing data and product scrap trend Analysis data


Quality Engineer Job Requirement:
  • Bachelor’s Degree in Science or Engineering.
  • 5+ years of experience in Quality Engineering in the medical device industry (or regulated industry). 
  • Experience in Manufacturing Quality is required.
  • Knowledge of FDA Quality System Regulation (21 CFR 820) and ISO 13485. 
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables simultaneously.
  • Strong mechanical aptitude and methodical problem-solving skills.
  • Strong oral and technical writing skills.
  • Basic statistical aptitude and experience with statistical sampling. 

Compensation for Quality Engineer:

 The starting salary for the Quality Engineer position is $60k to $70k annually (open to negotiation).
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