GENERAL SUMMARY:

Job #2309: The Supplier Quality Engineer is a key role, responsible for working with our development team and external suppliers to deliver high quality, life-saving products; from  development, through the life of the product.

Manage all aspects of tier one and sub-tier supplier quality activities for assigned suppliers/ commodities; drive quality and process improvement at assigned suppliers/commodities. Assess, monitor, and ensure the continued adequacy and effectiveness of the quality system for the assigned supplier base. Support supplier selection, supplier process validation/controls, general supplier development. Review and approve inspection sampling plans for selection parts.

MAJOR DUTIES/RESPONSIBILITIES:

  • Support new supplier audits, selection, development, and supply chain team strategies
  • Participate in design reviews with development teams and suppliers to ensure manufacturable designs
  • Manage supplier part/assembly qualifications using PFMEA/AQPQ/PPAP techniques
  • Manage supplier process validation plans, and reports using IQ/OQ/PQ validation techniques
  • Approve supplier test and inspection plans and procedures to ensure quality at the source
  • Maintain supplier key performance indicators (KPIs) to support supplier score cards, and drive improvements.
  • Drive supplier quality MRB dispositions, root cause determination, and 8D corrective actions/supplier corrective action requests (SCAR)
  • Utilize six-sigma and lean manufacturing techniques to Lead continuous improvement of supplier performance working with supply chain and development teams
  • Supplier primary technical contact working both independently and in teams to support company objectives
  • Maintain 100% compliance to our processes and procedures.
  • May participate in definition of critical-to-quality/process/function parameters for critical components/sub-systems.
  • Other related duties as assigned.

BASIC QUALIFICATIONS:

  • Bachelor’s degree in an engineering or technical science, or equivalent combination of education and directly relevant experience
  • 4 years’ directly relevant experience, with prior experience in a FDA/cGMP or regulated environment
  • Working knowledge of PPAP and IQ/OQ/PQ validation techniques
  • Strong written and verbal communication skills
  • Direct experience with fabrication and assembly manufacturing processes
  • Autonomous, independent worker, comfortable with minimal supervision and tight deadlines

PREFERRED/DESIRED QUALIFICATIONS:

  • 8+ years of experience in FDA/regulated environment
  • Team leadership and project management experience
  • Experienced with six-sigma and lean manufacturing techniques
  • Direct experience working with Over-molded Cable, PCBA, Contract Manufacturer, and ODM Suppliers
  • Certified quality auditor
  • Ability to drive and deliver innovative, effective and timely solutions

WORKING CONDITIONS:

  • Team oriented, friendly, fast-paced, and innovative environment
  • Ability to travel up to 20% of the time
  • Significant use of standard office software and equipment
  • Ability to lift up to 35 pounds

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