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Product Quality Engineer (PQE)

Goodwin Recruiting Freeburg, IL

  • Expired: September 10, 2021. Applications are no longer accepted.

The company is a world-class award-winning international medical equipment manufacturer, whose design and technology solutions are best-in-class. The company seeks to add a Quality Engineer - Product to its Global Quality Team to drive improvements within the quality management system in greater St. Louis.

Responsibilities of the Product Quality Engineer roleInvestigate non-conforming material and determine its dispositionSupport risk management activities, guided under ISO 14971, utilizing tools such as FMEA, Hazard Traceability Matrix, Fault Tree Analysis, and Root Cause AnalysisManage and analyze data for products, participating in Lean and Six Sigma activitiesIdentify and educate others on regulatory compliance standards that apply to products and manufacturing processesAttend educational workshops, seminars, and conferences; and review professional publications.Qualifications of the Product Quality Engineer roleBachelor' s Degree in engineering (mechanical preferred)Minimum of... two years of Quality Engineering experience in a manufacturing environmentFamiliarity with medical device regulations (21 CDR Part 820) and ISO 13485Experience utilizing Root Cause Analysis techniques (8D, 5-why, Ishikawa, Fault Tree Analysis)Experience implementing continuous improvement activities (Kaizen, 5S, Layered Process Audit)Understanding of statistical techniques and methods used to analyze quality dataCertified quality engineer and Medical Devices experience are preferredBenefits for the Product Quality Engineer roleMedical, Dental, Vision, LTD, Life/AD, Life/ADSupplemental Insurance Benefits401K with immediate vesting and matching up to 4%Vacation plus 136 hours awarded each JanuaryBonus for the region at year-endLocation/Region: Freeburg, IL (62243

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