Job Description

Description

Quality Engineer – Medical Tubing Extrusion

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.

Responds to: Director of Quality – Blownfilm Division Spectrum Plastics

• 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

• 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