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Supplier Quality Engineer II

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PTS Advance is looking to speak with Supplier Quality Engineers to join our client which is an international Medical Device organization that has multiple product lines ranging from Class 1 to Class 3 medical devices. In this role, you will be responsible for Quality Performance through the application of Advanced Product Quality Planning (APQP) during the industrialization of New Product Induction. You will also act as an internal and supplier quality auditor - managing, planning, executing, reporting, and closing audits and audit findings. This is a contract opportunity that is fully onsite in Pittsburgh, PA. 


Main Responsibilities
  • Supplier Quality Engineer (NPI) is responsible for achieving a state of high-quality performance through the application and practice of Advanced Product Quality Planning (APQP) during the industrialization of products/parts within the New Product Introduction NPI process. 
  • Develop and oversee equipment qualification and process validation plans and lead continuous improvement projects based on process/product trends, customer complaints, industry standards, and government regulations.
  • Assure quality systems of OEMs, manufacturers, and suppliers are maintained and acceptance criteria are in alignment with component/product use and customer expectations. 
  • Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes. 
  • Serve as internal and supplier quality auditor, managing planning, execution, reporting, and closure of audits and audit findings.
  • Experience with supplier control and design controls, and design ties to the supplier.

Required Qualifications
  • 15+ years of professional experience. 
  • Bachelor's/Master's degree or equivalent experience. 
  • Expert technical knowledge. 
  • Knowledge and experience with CPK, APQP, and Six Sigma.
  • New Product Line experience is mandatory. 

Not open for C2C.

If you or someone you know may be interested, please send your resume to Lisa.Oster@PTSadvance.com or visit us at jobs.PTSadvance.com to learn more about the role. #LifeSciences #PTSAdvancejobs #PTSAdvance