Cook Incorporated Quality Engineer - Complaint Investigation in Bloomington, Indiana

iQuality Engineer- Complaint InvestigationPosting Date 21 hours ago (12/21/2018 9:13 PM)Requisition ID 2018-4403 Job Location(s) Bloomington IN United States Shift Type First Position Type Full Time Company Cook Inc. Category QualityOverviewThe Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.ResponsibilitiesiPerform work per external and internal quality standardsInterface with internal and external groups on quality-related issuesSupport product development and transfer to manufacturingFacilitate development and implementation of production controls (e.g. qualification, process capability, sampling plans, validation, etc.)Perform investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issuesPlan, review, and approve change requestsExecute risk assessment as needed and facilitate development and completion of risk file documentationConduct Risk-based decision making and effective resolution of issuesLead or support CAPAs as necessaryMay interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.)Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.Provide leadership in the understanding of medical device regulations and best practicesManage conflict resolution as it relates to technical situationsMust work and interact effectively and professionally with and for others throughout various levels of the organizationMust strictly adhere to safety requirementsQualificationsBachelors degree in a scientific disciplineDemonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)Professional certification (e.g. ASQ, Six Sigma, etc.) preferredProficiency in statistical, quality and continuous improvement methods and toolsProficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.Strong organizational skillsCritical thinking and attention to detail requiredExcellent verbal communication skills and technical writingPhysical Requirements:Works under general office environmental conditions, including time in manufacturing environment and biohazard labSitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.Occasional travel may be requiredOptionsApply for this job onlineShareShare 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.iVEVRAA Federal ContractorEqual Opportunity Employerminorities/females/veterans/individuals with disabilities/sexual orientation/gender identity