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Quality Engineer Lead (Validation)

Company: Sterling Engineering, Inc.
Location: Buffalo Grove
Posted on: November 25, 2022

Job Description:

Overview:

The Quality Engineering Lead is a " hands-on" position responsible for planning, coordinating, and managing through completion, assigned projects to ensure the development and production of products meet customer and internal quality deliverables.




Responsibilities:

  • Responsible for qualification of mold, and processes from a quality and compliance standpoint
  • Create qualification plans for new assets
  • Oversee project deliverables
  • Create Validation Protocols and Reports, Product Specifications, and Change Control activities
  • Coordinate and manage the execution of validation protocols and change control requests.
  • Assess results of Customer Complaint investigations and Corrective Actions for application, validity, and conformance to FDA regulatory, QSR, ISO, and Customer requirements.



    Preferred/Required Education/Skills:
    • Bachelor' s degree in Engineering, Science, or a related field.
    • 5 or more years of experience in a Quality position within the Medical Device industry is required.
    • Technical writing experience preferred
    • Experience in the Medical Device industry preferred.
    • Clean room environment experience



      Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

Keywords: Sterling Engineering, Inc., Buffalo Grove , Quality Engineer Lead (Validation), Engineering , Buffalo Grove, Illinois

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