Business Systems and Change Analyst
Core
Process change orders and implement system/process improvements for Document Control in a medical device company, ensuring regulatory compliance and supporting PLM system updates.
Role type
Business Systems and Change Analyst
Builds
PLM system updates, Document Control process improvements, and regulatory-compliant documentation changes
Domain
Medical Devices / Regulatory Quality / Product Lifecycle Management (PLM)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Change control principles, PLM system knowledge, Agile methodology, Computer System Validation (CSV), regulatory compliance, process improvement, data integrity management, issue resolution, cross-functional collaboration
Preferred skills
Project management, advanced PLM technical functionality
Technologies
Agile, PLM systems, Microsoft Office (Word, Excel, Visio)
Responsibilities
Execute improvement activities for PLM and Document Control processes; represent Document Control in project requirements definition; create and execute test scripts for PLM projects; process and audit change orders for accuracy and compliance; update procedures and documentation upon implementation; resolve complex Document Control tickets; support Agile training forums; maintain data integrity in Agile forms; troubleshoot system issues and escalate to IT as needed
Seniority
Mid-Senior level (6-10 years experience)