Supplier Quality Engineer (Onsite - Acton, MA)

Supports the selection, qualification, and management of external suppliers to lnsulet. Closely works with manufacturers and service suppliers to ensure product/service quality meets lnsulet requirements.

Requirements

• Maintain approved supplier list and supplier history records in accordance with quality system requirements.
• Assist with the qualification of new suppliers, new components, and changes by developing and executing, in conjunction with other internal groups, a robust and complete set of plans and requirements for such qualifications.
• Maintains accuracy of Supplier Audit Reports and Supplier Profile
• Plans and conducts scheduled audits of suppliers to assess compliance with lnsulet Requirements.
• Communicates quality issues to suppliers as needed and aids development of corrective actions
• Initiate and follow up on supplier corrective actions for both audit deficiencies and internal non-conformances to ensure timely closure.
• Generates Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility
• Tracks and trends supplier performance, taking remedial action as needed
• Conduct and assist with internal audits
• Assist or leads CAPA evaluation and closure as related to the supplier quality processes and or supplier performance.
• Participate in developmental and departmental training
• Support Site during external audits (i.e. BSI, FDA, Customer).
• Performs other duties as required

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs