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