Quality Engineer I

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    "description": "<p><span style=\"font-size:12.0pt\"><span style=\"font-family:&quot;Cambria&quot;,serif\">The Quality Engineer is responsible for overseeing process control, risk management, and product quality assurance for the medical tubing extrusion, converting, and blown film processes at the Pleasant Prairie, Wisconsin site. This role ensures compliance with ISO and cGMP standards while driving improvements in product quality, addressing customer complaints, and managing Corrective and Preventive Actions (CAPA). The Quality Engineer will collaborate closely with cross-functional teams to resolve quality issues, ensure regulatory compliance, and enhance product performance. Additionally, this position will manage clean room operations, calibration activities, and the development of quality procedures to support ongoing process optimization.</span></span></p>\r\n\r\n<p>&nbsp;</p>\r\n\r\n<ul>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Act as a role model and ensure safety is built into our QMS and work processes.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Oversee process control activities within the tubing extrusion process to ensure product quality, minimize defects, and meet regulatory standards.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Manage customer complaints by investigating root causes, developing action plans, and ensuring timely resolution to maintain high customer satisfaction.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Lead the CAPA process, ensuring corrective and preventive actions are properly documented, tracked, and implemented to address any quality issues.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Collaborate with cross-functional teams to identify areas for improvement in the extrusion process, implementing solutions to enhance product quality and compliance.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Conduct root cause analysis and implement corrective actions for non-conformances, ensuring CAPA processes are followed and effectively closed.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Develop and maintain standard operating procedures (SOPs) to support and enhance the Quality Management System, ensuring ongoing regulatory compliance.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Monitor and manage clean room operations, ensuring adherence to ISO and internal standards for contamination control.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Supervise quality technicians, ensuring they are properly trained and follow standardized procedures for inspection and quality control.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Lead internal audits, identifying quality issues and ensuring corrective actions are implemented to maintain compliance with internal and external standards.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Participate in product validations, ensuring that new products meet quality standards and customer requirements before release.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Evaluate new product specifications, ensuring they are aligned with customer requirements and regulatory standards.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Generate detailed reports for management meetings, highlighting product quality, risk analysis, customer complaints, and CAPA performance.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Support training programs to ensure all employees are knowledgeable about quality procedures, process controls, and CAPA requirements.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Ensure full compliance with internal EHS policies, national laws, and industry regulations, maintaining a safe and compliant work environment.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Foster a strong focus on product quality assurance, ensuring all products meet specifications and regulatory standards.</span></span></li>\r\n</ul>\r\n\r\n<p><span style=\"font-size:12.0pt\"><span style=\"font-family:&quot;Cambria&quot;,serif\">Other duties as required. </span></span></p>\r\n",
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