Supplier Quality Engineer

Supplier Quality Engineer (Contract)

Sharon Hill, PA

Job Requisition: 6438
Description for Supplier Quality Engineer
In this role, you will assist in the administration of the quality functions, to assure adherence to ISO 9001 and other applicable regulatory standards. 
Responsibilities for Supplier Quality Engineer:
  • Assist in the administration of the quality functions for off-site sterilization centers
  • Assure adherence to ISO 9001 and other applicable regulatory standards. 
  • Coordinate document control transactions, site record retention, calibration and inspection activities. 
  • Facilitate Customer complaint investigations
  • Assist in audit coordination
  • Support supplier quality and customer assessments, and support risk management activities where appropriate
  • Track and trend Quality data and support the site Management Review process. 
  • Validation activities of equipment
  • Validate sterilization processes
  • Product Testing
  • Process and Product Validation Activities
  • Process Control Documentation improvements
Requirements for Supplier Quality Engineer:
  • 2+ years of experience in Supplier Quality Engineer, in a regulated industry (i.e. FDA/ISO). 
  • Must have knowledge of auditing and compliance requirements. 
  • Experience with the following quality related tasks:
    • Supplier quality performance monitoring
    • Customer complaint investigations
    • Process and/or equipment validation
    • Process Control Documentation
    • Incoming quality inspections
  • Clear oral and written communication skills a must. 
  • Experience navigating a computer, along with experience with Microsoft Office programs required; database program experience is a plus. 
  • Experience with ISO 9001, or other applicable ISO standards.

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