Quality Engineer I - Med Devices, CAPA & Process Control

PPC INDUSTRIES INC; Pleasant Prairie (WI); On-site; USD 70,000 - 90,000; Full time

Job summary

PPC Industries Inc is looking for a Quality Engineer at their Pleasant Prairie, Wisconsin site. This role oversees process control, ensuring compliance with ISO and cGMP standards while focusing on product quality and addressing customer complaints.

The ideal candidate will have a degree in Engineering, preferably Mechanical or Industrial, and at least three years of experience in the medical device industry. The position includes managing CAPA processes, leading quality improvements, and fostering collaboration among cross-functional teams.

Qualifications

• Minimum of three years experience in a medical device manufacturing environment.
• Experience in tubing extrusion with focus on quality control.
• Strong experience managing CAPA processes.

Responsibilities

• Oversee process control activities in tubing extrusion.
• Manage customer complaints and lead CAPA processes.
• Conduct root cause analysis for non-conformance.

Skills

CAPA processes

Statistical analysis

Clean Room Management

Problem-solving

Customer relations

Leadership

Education

Degree in Engineering (Mechanical or Industrial)

Six Sigma Certification

Internal ISO Auditor Certification

Tools

Minitab

MS Office Suite

Job description

PPC Industries Inc is looking for a Quality Engineer at their Pleasant Prairie, Wisconsin site. This role oversees process control, ensuring compliance with ISO and cGMP standards while focusing on product quality and addressing customer complaints.

The ideal candidate will have a degree in Engineering, preferably Mechanical or Industrial, and at least three years of experience in the medical device industry. The position includes managing CAPA processes, leading quality improvements, and fostering collaboration among cross-functional teams.