The Configuration Control Specialist is responsible for ensuring the consistency, quality, and compliance of Arineta’s product configurations throughout the product lifecycle. This role focuses on the management of configuration systems, ensuring alignment with regulatory requirements, and overseeing the engineering change process in accordance with Arineta’s procedures.
Responsibilities
• Implement, configure, and maintain Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems for product lifecycle documentation.
• Define and implement standard operating procedures for configuration control, including workflows, user permissions, and system interfaces.
• Manage the entire lifecycle of engineering changes, ensuring compliance with Arineta’s Engineering Change Order (ECO) procedures.
• Lead the Change Control Board (CCB) to review, approve, and implement engineering changes.
• Define KPI and crucial activities supporting quality engineers for Production line transfer processes and qualification.
• Maintain an accurate and up-to-date Device Master Record (DMR) database, ensuring proper version control and historical change retention for audits and investigations.
• Ensure that all product-related documentation, such as manufacturing instructions and control documents, are properly managed and archived.
• Manage the monitoring of rejected material and Supplier corrective action requests follow-up.
• Generate regular reports on the status of open and closed changes, including average cycle time and implementation status.
• Perform trend analysis to identify bottlenecks and opportunities for improving the configuration management process.
Competence and Authority
• Engineering Change Management
• Configuration Control Board (CCB) leadership
• System interfaces with PLM/ERP
• Version control and DMR oversight