Vacancy expired!
Location: Portage, MI Description: Our client is currently seeking a Senior Quality Assurance Engineer
THIS IS NOT AN IT POSITION This Quality Engineer role is in support of a recent acquisition, where the QMS of an acquired company must be merged with the existing QMS-Experience in process flow mapping and documentation desired.-Gather and analyze data to identify opportunities for quality improvements.-Drive failure investigation to root cause when applicable using known engineering problem solving techniques.-Lead and/or Support NC/CAPA process and NC/CAPA Investigations stemming from Post market.-Resolve Potential Medical device reporting(MDR) investigations.-Lead product failure investigations to completion.-Champion product failure investigations to closure.-Document each investigation thoroughly in accordance with internal procedures within complaint handling system(s).-Conduct/Update risk analyses and track all findings, along with development of Risk Management portfolio, as required.-Provide Service Report and Complaint trending.-Prior related experience in a regulated environment highly desired.-Prior related experience investigating, troubleshooting and root causing highly preferred.-Eagerness to assist internal and external customers-Manage projects in a timely manner-Participate in internal and external audits, as required.-Trackwise Experience highly desired.Additional Job Details: -This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. -Bachelors Degree required, with area of study in science or engineering preferred. -Minimum of 2 or more years experience preferred. -Job requires an understanding and application of procedures and concepts of own discipline. -The job requires attention to detail in making evaluative judgements based on the analysis of factual information. -Competent with Microsoft Office (Outlook, Excel, Word, etc.) -Must possess excellent oral and written communication skillsContact: This job and many more are available through The Judge Group. Find us on the web at www.judge.comVacancy expired!