Supplier Quality Engineer

The Supplier Quality Engineer is responsible for supporting supplier quality processes within Novidan’s R&D process, manufacturing facility and supply chain. She or he will be responsible for product quality from suppliers through to the field. The engineer will be responsible for improving Novidan systems in the areas of supplier quality, responding quickly to determine root cause and communicating clearly on any issues therein.

JOB RESPONSIBILITIES

  • Responsible for product quality from suppliers to Novidan and in the field.
    • Own and enhance supplier qualification process
    • Implement supplier quality metrics and scorecard
    • Support and improve supplier change notification process
    • Troubleshoot supplier related product failures in production and the field
    • Determine root cause analysis on supplier failures quickly
    • Clearly communicate issues to supplier and Novidan employees
    • Drive product improvements with suppliers
    • Manage supplier relationships and act as an internal liaison with the supply chain
  • Support R&D and continuation engineering projects as the supplier quality representative
  • Continually improve Novidan’s and supplier’s processes and production material flow
  • Actively participate in the Material Review Board
  • Interface with key suppliers on Quality subjects and issues
  • Initiate supplier investigations and manage Supplier Corrective Action Requests
  • Conduct quality audits internally and externally at suppliers domestically and overseas
  • Write excellent test reports, inspection procedures, and process documents
  • Capture, manage, and report on production and field data, using statistical analysis tools
  • Support and assist other areas of Quality, as needed

JOB REQUIREMENTS

  • Minimum B.S. in a related Engineering field
  • Must have 3+ years of experience in a regulated product field
  • Experience with medical devices and ISO 13485:2016, a significant plus
  • Six Sigma Green Belt or Black Belt a plus
  • Must have excellent writing skills
  • Must be able to clearly present data to a group of technical staff.
  • Advanced user of Excel and Minitab
  • Intermediate to advanced knowledge of statistical analysis methods and tools
  • Self-starter, resourceful and able to achieve results with minimal supervision

WORKING ENVIRONMENT

Normal office and light manufacturing conditions. Mobile work flexibility available.

TRAVEL EXPECTATIONS

Less than 10%. Some US or international travel may be required to visit suppliers.