Description

Summary: The Quality Engineer Extrusion is tasked with the development and implementation of the Quality Management System related to tubing extrusion at the Pleasant Prairie, Wisconsin site. The Quality Engineer Extrusion also oversees cGMP's and compliance of the clean room to ISO and internal requirements.

• Supervision of quality technicians.
• Support to the Quality Manager in daily site events and general requirements.
• Supervision of calibration activities as defined by standard operating procedures.
• Develop standard operating procedures that support the Quality Management System.
• Coordinate and execute activities related to clean room controls when appropriate.
• Manage Customer complaints
• Participate in product validations when necessary.
• Evaluate new product specifications when necessary.
• Perform measurement system analysis when necessary.
• Coordinate continuous improvement projects in the area.
• Coordinate internal audits when necessary.
• Execute the necessary technical writing.
• Interact with customers to resolve quality problems.
• Generate the necessary information for the Management Meeting required by the quality system.
• Management of the training system.
• Management of the documentation system.
• Perform risk analysis and create individualized control plans.
• Generate weekly and monthly reports that will be shared with the Corporation.
• Responsible for fully complying with the company's internal EHS policies, associated national laws and any others of which they are aware.
• Maintain the commitment to Zero injuries, illnesses and professional incidents; They are all preventable.
• Responsibly resolve circumstances that require corrective actions.
• Any other similar function that is of the same type as those that make up the activity.
• Other duties as required.

Qualifications

Academics

• Degree in Engineering (Mechanical or Industrial)
• Six Sigma Certification (desirable)
• Internal ISO Auditor (desirable)

Knowledge base

• MS Office Suite
• Minitab and advanced Statistical Knowledge (Gage RR, Hypothesis Testing, DOE, etc.)
• Risk Management
• Clean Room Management (Cleaning Schedule, Non-Viable and Viable Particle Counts)
• Tubing extrusion experience

Work Experience

• Minimum of three years in medical device manufacturing experience, continuous improvement and experience in tubing extrusion (desirable)

Competencies

• Problem Solving and Analytics
• Customer facing skillsets
• Leadership experience
• Communication