Quality Engineer (Manufacturing - medical devices)

Position: Quality Specialist Reports to: Head of Quality and Regulatory Status: Exempt NOTE: This is an onsite role based out of our Addison, Illinois office with no sponsorship available at this time. Responsibilities Support migration of documents into an eQMS, perform testing and validation Perform Admin roles (Document, Training, Sysadmin, etc.) within the eQMS Manage DCR/ECO process for documentation and QMS record retention Identify training needs for new and current employees, create plans and maintain records Perform internal audits and support with notified body audits/responses Performing product/process failure investigations, identifying root cause, trending, and supporting CAPA activities Perform component and product inspection and investigation of non-conformance. Available on-site to perform initial review and final release of routers for production activities. Assist production with non-conformances identified on production line. Host Material Review Board (MRB) meetings for Non Conformance Report(NCR) and work with Purchasing for vendor issues and Supplier Corrective Action Request(SCAR) Collect and review scrap data alongside dispositioning product with management Manage the calibration program by tracking equipment and working with Purchasing for quotes and shipments to vendors Upkeep of test, maintenance and environmental monitoring records for the plant Apply in depth knowledge of FDA 21 CFR Part 820 as it pertains to Medical Devices to maintain ISO 13485 certification and continuously improve QMS through process enhancements Assist in regulatory activities including but not limited to registrations, Adverse Event Reports, UDI implementation and compliance with regulation changes Collect, analyze, provide and present data for projects and management meetings Other projects, as assigned by the Head of Quality and Regulatory Affairs Qualifications High School Diploma, Associates degree or Equivalent. B.S. Degree in Science or Engineering is a plus 4+ years of experience, preferably in a manufacturing/ISO 13485 certified setting Excellent written and oral English skills, Spanish language is a plus Good documentation skills, attention to details, tracking tasks and paperwork filing Good computer skills with Word, Excel, MS Outlook; ERP systems and Adobe preferred; Experience with eQMS is required (MasterControl, GreenlighGuru, etc.) Basic knowledge of ISO 13485 and FDA regulations Demonstrated experience working with cross-functional teams Ability to initiate and drive continuous process improvements Understanding drawings, using measuring tools for product inspection and calibration Willingness and ability to work evenings and weekends as needed Preferred to have experience with Class I and II medical devices Preferred to have experience handling ISO/FDA audits #J-18808-Ljbffr Burton Medical