SICR Owner - SICR Owner - Centre of Excellence, Global Supplier Quality
Core
Manage end-to-end Supplier Initiated Change Request (SICR) processes, coordinate cross-functional impact assessments, and drive governance for supplier changes in a medical device Quality Management System.
Role type
Senior process owner / Quality Management System specialist
Builds
Global supplier change management workflows and compliance frameworks
Domain
Medical devices / Regulatory Quality Management
Required skills
Supplier relationship management, change impact assessment, regulatory compliance (ISO 13485/21CFR Part 820), process governance, data analysis, stakeholder coordination, risk management
Preferred skills
Program management, digitalization/automation initiatives, conflict resolution, continuous improvement methodologies
Technologies
Excel, Power BI, Tableau, PowerPoint
Responsibilities
Own and manage the end-to-end SICR process from submission to closure; Coordinate cross-functional evaluations of supplier-proposed changes; Serve as primary interface between suppliers and internal stakeholders; Monitor and report SICR performance metrics; Ensure compliance with QMS requirements and regulatory standards
Seniority
Senior, hands-on IC