Cook Incorporated Quality Engineer- Nonconformance in Bloomington, Indiana

Quality Engineer- NonconformancePosting Date 20 hours ago (1/7/2019 10:04 PM)Requisition ID 2019-5799 Job Location(s) Bloomington IN United States Shift Type First Position Type Full Time Company Cook Inc. Category EngineeringOverviewThe Non conformance Quality Engineer serves as the quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.Responsibilities- Perform work per external and internal quality standards.- Interface with internal and external groups on quality-related issues.- Perform investigation of product non-conformances and/or processes.- Conduct Risk-based decision making and effective resolution of issues.- May interface with internal or 3rd party audits. (e.g. FDA, Notified Body, etc.)- Manage conflict resolution as it relates to technical situations.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments withminimal supervision.- Ability to remain calm and receptive in fast paced situations.Qualifications- Bachelors degree in a scientific discipline or experience of such kind and amount as to provide a comparable background.- Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)- Professional certification (e.g. ASQ, Six Sigma, etc.) preferred.- Proficiency in statistical, quality and continuous improvement methods and tools.- Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.- Strong organizational skills.- Critical thinking and attention to detail required.- Excellent verbal communication skills and technical writing.- Works under general office environmental conditions, including time in manufacturing environment and biohazard lab.- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.- Occasional travel may be required.OptionsApply for this job online ApplyShareShare the job posting with a friend ReferSorry the Share function is not working properly at this moment. Please refresh the page and try again later.Share on your newsfeed"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state, and local law.VEVRAA Federal ContractorEqual Opportunity Employerminorities/females/veterans/individuals with disabilities/sexual orientation/gender identity