Job Title: Supplier Change Notification (SCN) Engineer
Work location: Galway, Ireland
Duration: 1+ Years of Contract
Role Overview
The Supplier Change Notification (SCN) Engineer will support the Supplier Quality and Engineering teams in the review, assessment, and management of supplier change notifications to ensure continued product quality, regulatory compliance, and supply continuity.
The role will work cross-functionally with Supplier Quality, Design Engineering, Regulatory Affairs, Manufacturing, and Supply Chain teams to evaluate supplier-driven changes and coordinate necessary impact assessments, validations, and documentation updates.
Key Responsibilities
Review and assess incoming Supplier Change Notifications (SCNs) from component and material suppliers.
Coordinate cross-functional review of supplier changes with Supplier Quality, Engineering, Manufacturing, and Regulatory teams.
Track supplier change notifications through the internal change control process.
Conduct initial impact assessments of supplier changes on product specifications, materials, manufacturing processes, and regulatory compliance.
Support risk assessments to determine potential product, quality, and supply chain impacts.
Work with engineering teams to determine if supplier changes require verification, validation, or additional testing.
Coordinate activities related to design evaluation, process validation, or product qualification where required.
Documentation & Compliance
Ensure supplier changes are documented and managed in accordance with Quality Management System (QMS) procedures.
Support updates to relevant documentation including specifications, supplier records, and technical documentation where required.
Cross-Functional Collaboration
Act as a coordination point between Supplier Quality, Engineering, Regulatory Affairs, Manufacturing, and Supply Chain teams.
Communicate with suppliers and internal stakeholders to ensure timely evaluation and resolution of supplier changes.
Required Experience
Experience in Supplier Quality, Quality Engineering, or Change Management in a regulated manufacturing environment.
Familiarity with supplier change notification or supplier change management processes.
Experience working within regulated environments such as FDA, EU MDR, or ISO 13485 quality systems.
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