Quality Engineer With Medical Device

2 weeks ago


Grand Rapids, United States Master Compliance Full time

Experience:

  • Assist in setting up robust injection molding processes on multi-cavity molds and insert molding.
  • Experienced in the ability to partner and coordinate supplier qualification activities (PPAP, IQ, OQ, PQ, DOE, etc) to meet requirements of the application.
  • Proficient in generating qualification requirements and reports for injection molded components.
  • Understands limits / fits, tolerance stack up analysis. Highly experienced in Geometric Dimensional Tolerancing (GDT) and application for inspection setup and tolerancing allowances of molded components
  • Use and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis/Gage R&R, Process Capability and Statistical Process Control)
  • Experience leader of cross functional teams including R&D, Marketing, Manufacturing, Regulatory, Quality, Sourcing and Supply Chain through qualification processes
  • Develop and maintain strong working relationship with functional groups (R&D, ME, Quality Operations, Supply Chain and Regulatory)
  • History of mentoring team members


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