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Supplier Quality Engineer

4 months ago

Colorado Springs, United States Eliassen Group Full time

Responsibilities

  • Act as SQE lead to drive the Supplier Qualification and Part Qualification for Vasper Products.
  • Responsible for Supplier Quality Performance Monitoring, assisting in the development of Quality processes relating to Supplier Quality Control’s, works with the team to assist in supplier audits and supplier qualification, assessing supplier capabilities, supplier quality controls, adherence to design outputs, audit and inspection experience, experience with supplier control and design controls, and design ties to supplier.
  • Knowledge or experience with CPK, APQP, Process Capability Statistics in relation to Six Sigma which is essentially process optimization
  • Drive supplier improvement via SQIP (Supplier Quality Improvement Plans).
  • Experienced in Electro-mechanical and Stent Commodity


Qualifications

  • Bachelor of Science Degree in Engineering. Mechanical or Electrical
  • Minimum 7 years’ experience, with medical device experience required
  • Minimum three years of GMP manufacturing experience required
  • Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology
  • Mechanical and electronic ability aptitude to assist with equipment troubleshooting
  • Understanding of and adherence to GMP practices and FDA regulations