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TekWissen llc

Quality Engineer- Medical Device Manufacturing

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Description

  • Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers.
  • Develops and implements corrective/preventative action plans.
  • Collects and analyzes data for gauge and product evaluation.
  • Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
  • Ensures that suppliers have necessary information and facilities to deliver quality products

  • Ability to deliver, meet deadlines and have results orientation.
  • Able to communicate both orally and in written form to multiple levels of the company.
  • Demonstrates characteristics of high potential for future development opportunities.
  • Microsoft Office Suite
  • Basic knowledge of blueprint reading and geometric dimensioning and tolerancing, basic understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.

B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE) plus 3 years experience in a Quality Engineering role, or an equivalent combination of education and experience.
Certified Quality Engineer (CQE) preferred.

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