Quality Engineer

Job Details

Job Location:

PPC
- Pleasant Prairie
- Pleasant Prairie, WI 53158

Position Type:
Full Time

Job Shift: 1st Shift

• 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.
• 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.