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Quality Engineer II

Company: Indotronix International Corporation
Location: Vernon Hills
Posted on: May 13, 2022

Job Description:

Purpose of Position : The Quality Engineer II is responsible for supporting Design Quality Assurance within the Infection Prevention Platform: Design Controls, Risk Management, Human Factors / Usability Engineering. The incumbent works multifunctionally with teams on new product design, design transfer, risk management, process/product design, quality improvement projects (QIPs) and change to win (CTW) projects.Job Requirements:Knowledge, Education, and Skills Required: Education This position requires a Bachelor of Science degree in Chemistry or Engineering from an accredited four (4) year university.Experience --- Bachelor's degree in Engineering or Chemistry from an accredited four (4) year university. --- Minimum 3 years Design Control and Risk Management experience with medical devices. --- Pharmaceutical background and knowledge of combination products, preferred. --- Experience operating in and auditing GMP, GLP.Specialized Knowledge Strong familiarity with regulatory requirements (FDA 21CFR -210&211, 21CFR -820, ISO 13485, CMDR, MDD/EU MDR, and J-PAL), particularly Design Controls and Risk Management (ISO14971), Statistical software (Minitab) knowledge and Six Sigma Methodology a plus. ASQ Certification(s) (e.g., Quality Engineering/Auditing) a plus.

Keywords: Indotronix International Corporation, Arlington Heights , Quality Engineer II, Engineering , Vernon Hills, Illinois

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