Quality Assurance Specialist

1 month ago


Pleasant Prairie, Wisconsin, United States Spectrum Plastics Master Full time
Job Title: Quality Engineer I

At Spectrum Plastics Master, we are seeking a highly skilled Quality Engineer I to join our team. As a Quality Engineer I, you will play a critical role in ensuring the quality of our medical tubing extrusion products.

Key Responsibilities:
  • Develop and implement the Quality Management System related to tubing extrusion at our Pleasant Prairie, Wisconsin site.
  • Oversee cGMPs and compliance of the clean room to ISO and internal requirements.
  • Supervise quality technicians and support the Quality Manager in daily site events and general requirements.
  • Develop standard operating procedures that support the Quality Management System.
  • Coordinate and execute activities related to clean room controls when appropriate.
  • Manage customer complaints and participate in product validations when necessary.
  • Evaluate new product specifications and perform measurement system analysis when necessary.
  • Coordinate continuous improvement projects in the area and execute internal audits when necessary.
  • Perform technical writing and interact with customers to resolve quality problems.
  • Generate weekly and monthly reports that will be shared with the Corporation.
  • Manage the training system, documentation system, and perform risk analysis and create individualized control plans.
Requirements:
  • Degree in Engineering (Mechanical or Industrial)
  • Six Sigma Certification (desirable)
  • Internal ISO Auditor (desirable)
  • Knowledge base in MS Office Suite, Minitab, and advanced Statistical Knowledge (Gage RR, Hypothesis Testing, DOE, etc.)
  • Risk Management and Clean Room Management (Cleaning Schedule, Non-Viable and Viable Particle Counts)
  • 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

We are committed to providing a safe and healthy work environment for all employees. As a Quality Engineer I, you will be responsible for fully complying with the company's internal EHS policies, associated national laws, and any others of which you 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.



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