Quality Engineer 1, Supplier

About the role

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 Supplier Change Notifications or other change control activities related to Supplier Quality
• Work and interact effectively and professionally with and for others throughout various levels of the global organization
• Strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Maintain company quality and quantity standards

Skills

• Effective oral and written communication skills
• Excellent problem-solving skills
• 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

• Bachelor’s 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