Job Details
Job Location
PPC Pleasant Prairie - Pleasant Prairie, WI
Position Type
Full Time
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 – Blown Film 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
