Supplier Quality Engineer

Insulet Corporation; Selangor; Presencial; MYR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Insulet Corporation is seeking a Supplier Quality Engineer to support the selection, qualification, and management of suppliers. You will ensure product and service quality meets Insulet requirements and communicate quality metrics across the organization and with external parties.

You will maintain supplier records, develop qualification plans, conduct audits, document findings, and drive CAPA activities to ensure timely closure and effectiveness across the supplier base.

Responsabilidades

• 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
• Develop and maintain the Supplier Audit Schedule to ensure supplier audits are scheduled per internal procedure.
• Plans and conducts scheduled audits of suppliers to assess compliance with Insulet Requirements.
• Prepares Audit Reports to document audit findings and observations.
• Communicates quality issues to suppliers as needed and provides assistance to develop corrective actions.
• Initiate and follow up on supplier CAPA for both audit deficiencies and internal non-conformances to ensure timely closure and effectiveness.
• Generates Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility.
• Tracks and trends supplier performance via supplier scorecards, 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).

Descripción del empleo

Responsibilities

Job Summary

Reporting directly to the Manager, Supplier Quality, the Engineer, Supplier Quality is responsible to support the selection, qualification, and management of suppliers. Closely works with suppliers to ensure product/service quality meets lnsulet requirements. Interfaces with other Insulet departments/functions as well as with suppliers and other external parties on issues related to product/service quality. Effectively communicates Quality metrics through supplier scorecards and Management Review to the organization, suppliers, and Executive Management.

• 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
• Develop and maintain the Supplier Audit Schedule to ensure supplier audits are scheduled per internal procedure.
• Plans and conducts scheduled audits of suppliers to assess compliance with lnsulet Requirements.
• Prepares Audit Reports to document audit findings and observations.
• Communicates quality issues to suppliers as needed and provides assistance to develop corrective actions.
• Initiate and follow up on supplier CAPA for both audit deficiencies and internal non-conformances to ensure timely closure and effectiveness.
• Generates Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility.
• Tracks and trends supplier performance via supplier scorecards, 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).