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.

Requirements

• 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