Quality Systems Manager

Our client a Global Chemical Manufacturer, is looking to add a Quality Systems Manager to their Flexibles & Fluids Division in Niles, Illinois.

• Management Representative to Maintain the Quality Management System (QMS)
• Interface with all internal departments in order to drive continuous quality improvement within the organization
• Maintain certification of the QMS to applicable standards as determined by executive management (e.g. ISO 13485)
• Manage the company’s verification (inspection) activities including quality inspection staff
• Develop and write QMS documents (procedures, work instructions, forms, etc.) and manage document control to comply with customer, company, and regulatory requirements.
• In conjunction with the Material Review Board (MRB) manage the resolution of non-conformances using root cause analysis, corrective/preventive action (CAPA) plans, and verification of effectiveness
• Analysis and management of risk, using such tools at FMEA (Failure Mode and Effects Analysis)
• Perform statistical analysis of processes and product conformance using methods such as Minitab “6-packs”, and other statistical tools
• Measure and improve metrology (measuring) system performance, including Gage R&R studies
• Provide failure analysis for items returned from customers or from production retain samples
• Execute the Production Part Approval Process (PPAP) per customer requirements
• Coordinate internal and customer requested validations of processes, equipment, and materials
• Track and document Improvement Action Reports (IARs)
• Compile metrics related to the Quality Management System (QMS) and department objectives and prepare reports on quality performance data
• Lead the development of quality goals
• Create and conduct training classes for production and administrative personnel in order to ensure the on-going effectiveness and improvement of the QMS
• Compile and analyze metrics regarding product quality and recommend corrective action necessary to ensure conformity with quality specifications and standards
• Lead the internal and external Audit Program and identify opportunities to refine processes and practices where possible to improve the overall value of the QMS
• Other duties as assigned.

• Prior experience in manufacturing, preferably in medical device packaging or medical device manufacturing
• Bachelor’s degree from a four-year college or university and one to two years related experience and/or training; or equivalent combination of education and experience
• Continuous improvement, Six Sigma training and/or certification preferred
• Experience with ISO 13485 and 21 CFR Parts 11 and 820 for medical devices
• Experience with Minitab or other QA software preferred
• Strong proficiency in Microsoft Office software including Excel, PowerPoint and Word
• Excellent interpersonal skills
• Prior experience working with a high level of autonomy
• Demonstrated experience in being well-organized, able to design quality management systems, and detail oriented
• Good communication skills with the ability to speak, read, and write English fluently