Quality Engineer 1, Supplier

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.

• 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

• 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.