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.
