Quality Engineer

Designation: Quality Engineer

Location: USA


  • Identify and review Part Qualification documents such as First Article Inspection, Gage R&R, Process Failure Mode Effect Analysis, capability study, control plan, process validation etc.
  • Develop requirements for quality inspection of incoming material from supplier.
  • Conduct supplier audits and manage audit corrections.
  • Facilitate the completion of Supplier Corrective Action Request and Vendor Quality Notices from supplier.  Perform activities to build Design History File and Device Master Record documents.
  • Perform gap analysis to update procedures and documentation to meet the new European Medical Device Regulation.
  • Conduct DFx reviews with external suppliers.
  • Perform manufacturing line 5S reviews.
  • Participate in Root cause investigations. Identify and Mitigate Quality Risk inside plant.
  • Participate in engineering design reviews and provide inputs.
  • Review and disposition product design and manufacturing process changes orders.
  • Perform manufacturing area audit to review compliance to FDA 21 CFR Part 820 regulation.
  • And any additional duties as deemed necessary for the project.

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