Supplier Quality Engineer I

Position Summary:
The Supplier Quality Engineer I will provide supplier quality input and support for products manufactured by Bracco/ ACIST Medical Systems. This role collaborates with the Supplier Quality team to deliver results that improve products and identifies areas of improvement. This role also provides direction in product risk management throughout the entire lifecycle and assure compliance to ACIST design control procedures, applicable regulations, and external standards. The role works upstream and downstream ensuring the total product lifecycle is maintained and that our products continue to perform as designed.

Primary Duties & Responsibilities:

Supplier Quality
• Participate in and lead supplier evaluation, qualification and approval activities including audits.
• Provide quality support for incoming inspection plans, procedures, and sampling methods to ensure product quality.
• Assist in defining critical attributes and characteristics to be measured for components and products.
• Define component qualification plans and approve first part review results.
• Own and complete Supplier Corrective Action Requests (SCAR), interfacing directly with suppliers.
• Oversee supplier validations, change orders, and any changes to form, fit, or function of the device.
• Provide direction and oversight to manufacturers for quality concerns, product inquiries, validations, safety, etc.
• Identify, Develop, and Implement systems that foster collaboration and communication with suppliers.
• Establish robust measures for supplier quality performance, monitor results regularly, and initiate appropriate actions to continually improve supplier quality performance.
• Participate in and lead continuous improvement projects
• Manage Supplier scorecards and monitor overall health of Supplier.

Receiving Inspection and Manufacturing Quality Assurance:
• Resolve NCMRs related to incoming material inspections.
• Assist in defining critical attributes and characteristics to be measured for components and products.

Material Review Board:
• Manage and the material review board for Operations including data generation and analysis, meeting execution, any follow up activities, meeting minutes, and filing of all MRB records.
• Generate Supplier Scorecards with the assistance from Global Supply Chain and Quality Engineering.