Quality Engineer at SaniSure in Twinsburg, Ohio, United States, ensures that products manufactured at the Twinsburg facility comply with applicable regulatory requirements, ISO 13485, and the company’s Quality Management System (QMS). This role collaborates with Operations, Manufacturing Engineering, Maintenance, and Quality teams to support manufacturing operations, maintain the QMS, facilitate batch record release, investigate quality events, resolve customer complaints and technical requests, and drive continuous improvement to ensure product quality and regulatory compliance throughout the product lifecycle. Key responsibilities include root cause investigations, CAPA and nonconformance management; collaborating with Operations and Engineering to resolve quality issues affecting production and product transfers; supporting internal, customer, and ISO audits as a Quality SME and participating in corrective actions from audit findings; driving continuous improvement initiatives related to extrusion processes to improve product quality, reduce scrap, and optimize manufacturing performance; maintaining current knowledge of evolving regulatory requirements and industry standards; authoring, reviewing, revising, and approving SOPs, work instructions, quality records, and other controlled documentation; investigating nonconformances, deviations, manufacturing issues, and customer complaints using 8D, 5-Why, and Fishbone analysis; managing CAPA investigations and effectiveness checks; reviewing and disposition of nonconforming materials, deviations, change controls, and manufac

Quality Engineer at SaniSure in Twinsburg, Ohio, United States, ensures that products manufactured at the Twinsburg facility comply with applicable regulatory requirements, ISO 13485, and the company’s Quality Management System (QMS). This role collaborates with Operations, Manufacturing Engineering, Maintenance, and Quality teams to support manufacturing operations, maintain the QMS, facilitate batch record release, investigate quality events, resolve customer complaints and technical requests, and drive continuous improvement to ensure product quality and regulatory compliance throughout the product lifecycle. Key responsibilities include root cause investigations, CAPA and nonconformance management; collaborating with Operations and Engineering to resolve quality issues affecting production and product transfers; supporting internal, customer, and ISO audits as a Quality SME and participating in corrective actions from audit findings; driving continuous improvement initiatives related to extrusion processes to improve product quality, reduce scrap, and optimize manufacturing performance; maintaining current knowledge of evolving regulatory requirements and industry standards; authoring, reviewing, revising, and approving SOPs, work instructions, quality records, and other controlled documentation; investigating nonconformances, deviations, manufacturing issues, and customer complaints using 8D, 5-Why, and Fishbone analysis; managing CAPA investigations and effectiveness checks; reviewing and disposition of nonconforming materials, deviations, change controls, and manufac