Iris Ortiz

About Iris Ortiz

Talented professional with diversified documentation management experience with…

Experience

1. Sr Document Control Specialist Configuration Assurance Adm

   Medtronic

   Mar 2016 — Present · Fort Worth, TX, US

   Conduct compliance review of all quality system document submissions (ECN – Engineering Change Notices and CAR - Change Action Request) to our QMS requirements. Identify any non-compliance issues & effectively communicate to requestors in a clear and concise manner these discrepancies; monitor and trend these occurrences utilizing both Net-Regulus, Excel and other reporting tools. • Facilitate the timely change, approval and release of product documentation and data to include ECN’s, Device Master Record authorization documents, product/model numbers, Product BOM /Router /DIR / Master Record information in SAP, manufacturing processes, and document archiving. • Facilitate the timely change, approval and release of Quality System documents to include SOP’s, Quality Forms, Quality Manual, and Sector SOP’s utilizing the Documentum application. This includes assisting with customer service support on document editing, content structure, QMS impact, and the routing / approval process. • Assist in the creation, maintenance, and implementation of department processes, procedures, and work instructions as required to demonstrate compliance with the Quality System. • Assist in monitoring configuration management process effectiveness including the impact of changes and take the initiative to recommend configuration management process improvements to lead or supervisor. • Work with team members to resolve issues arising from day to day operations • Partner with other functional areas internal and external to the department to facilitate process improvements. • Assist in providing hands on training and consultation to clients on the use of the Documentum and other department tools as required such as (SAP BOM / Router / DIR / Master Record information). • Participate in and lead special projects as assigned

Skills

• Process Improvement
• Adobe Acrobat
• 21 Cfr Part 11
• Validation
• Microsoft Office
• Microsoft Excel
• Standard Operating Procedure (Sop)
• Team Building
• Software Documentation
• Operations Management
• Change Control
• Manufacturing
• Cross-Functional Team Leadership
• Regulatory Affairs
• Quality Assurance
• Computer System Validation
• Quality System
• Quality Control
• Gmp
• Pharmaceutical Industry
• Sop
• Fda
• Poe
• Capa
• Team Leadership