Quality Engineer I

The Quality Engineer is responsible for overseeing process control, risk management, and product quality assurance for the medical tubing extrusion 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.

• Act as a role model and ensure safety is built into our QMS and work processes.
• Oversee process control activities within the tubing extrusion process to ensure product quality, minimize defects, and meet regulatory standards.
• Manage customer complaints by investigating root causes, developing action plans, and ensuring timely resolution to maintain high customer satisfaction.
• Lead the CAPA process, ensuring corrective and preventive actions are properly documented, tracked, and implemented to address any quality issues.
• Collaborate with cross-functional teams to identify areas for improvement in the extrusion process, implementing solutions to enhance product quality and compliance.
• Conduct root cause analysis and implement corrective actions for non-conformances, ensuring CAPA processes are followed and effectively closed.
• Develop and maintain standard operating procedures (SOPs) to support and enhance the Quality Management System, ensuring ongoing regulatory compliance.
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• Monitor and manage clean room operations, ensuring adherence to ISO and internal standards for contamination control.
• Supervise quality technicians, ensuring they are properly trained and follow standardized procedures for inspection and quality control.
• Lead internal audits, identifying quality issues and ensuring corrective actions are implemented to maintain compliance with internal and external standards.
• Participate in product validations, ensuring that new products meet quality standards and customer requirements before release.
• Evaluate new product specifications, ensuring they are aligned with customer requirements and regulatory standards.
• Generate detailed reports for management meetings, highlighting product quality, risk analysis, customer complaints, and CAPA performance.
• Support training programs to ensure all employees are knowledgeable about quality procedures, process controls, and CAPA requirements.
• Ensure full compliance with internal EHS policies, national laws, and industry regulations, maintaining a safe and compliant work environment.
• Foster a strong focus on product quality assurance, ensuring all products meet specifications and regulatory standards.
• Other duties as required.

• A degree in Engineering, preferably Mechanical or Industrial Engineering.
• Six Sigma Certification (desirable) to support process control and quality improvement efforts.
• Internal ISO Auditor certification (desirable) to lead audits and ensure compliance with ISO standards.
• Proficiency in MS Office Suite for data analysis, reporting, and documentation.
• Advanced statistical analysis skills with experience in tools such as Minitab, Gage R&R, Hypothesis Testing, and Design of Experiments (DOE).
• Strong experience with CAPA processes, implementing corrective and preventive actions to address quality issues and ensure compliance.
• Clean Room Management experience, including managing cleaning schedules and contamination control measures.
• Tubing extrusion experience, with a focus on quality control and process optimization.
• A minimum of three years of experience in a medical device manufacturing environment, with expertise in product quality assurance and risk management.