Quality Engineer 1, Supplier
Winston Salem, NC - USA
Department:
Job Summary
Overview
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.
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
Qualifications
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
Physical Requirements:
Works under general office conditions
Sitting for extended periods utilizes close visual acuity for working with computers equipment etc.
Ability to travel up to 20% of the time.
Required Experience:
IC
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.