Quality Engineer

7 days ago


Pleasant Prairie WI United States Spectrum Plastics Group, A DuPont Business Full time

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


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