Quality Specialist; Manufacturing

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.

• 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

• 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 (Master Control, Greenligh Guru, 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