Quality Engineer 1, Supplier

Cook GroupWinston-Salem, NC
Onsite

About The Position

The Supplier Quality Engineer is responsible for monitoring and maintaining supplier quality performance by supporting qualification activities, risk assessments, and nonconformance investigations. This role works cross-functionally to ensure incoming materials and supplier processes meet quality and regulatory requirements.

Requirements

  • Bachelors degree or equivalent experience in a technical discipline; or experience of such kind and amount as to provide a comparable background
  • Knowledge of quality tools & principles (i.e. risk assessment)
  • Knowledge of medical device regulations, pertinent standards and guidances

Responsibilities

  • Maintain, assess and monitor supplier quality
  • Coordinate and perform supplier qualification activities
  • Perform Supplier Scorecards and Risk Assessments
  • Collect supplier data
  • Investigate raw material nonconformities
  • Facilitate resolution of raw material nonconformities
  • Conduct and support supplier audits as needed
  • Track and review Supplier Corrective Actions
  • Participate on CAPA teams
  • Review of Supplier Change Notifications or other change control activities related to Supplier Quality
  • Must work and interact effectively and professionally with and for others throughout various levels of the global organization
  • Must strictly adhere to safety requirements
  • Maintain regular and punctual attendance
  • Must maintain company quality and quantity standards
  • Must have effective oral and written communication skills
  • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
  • Ability to remain calm and receptive in fast paced situations
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