Catherine Danca

About Catherine Danca

Global Quality & Regulatory Leader with 20+ years of experience in medical device quality…

Experience

1. Global Audit Program Manager

   Accuray

   Sep 2022 — Present · Madison, WI, US

   Develop, execute and maintain process, tools and resources for external audits and internal audits, including notified body, product technical file and country GMP QMS audits to maintain certifications to MDSAP, ISO 13485, EU MDR, UKCA including but not limited to other countries China, Korea, PMDA. In 2025, led the organization to pass the CFDI Overseas Audit with minimal nonconformities.

Education

• GE Crotonville

  Project Management

• GE Crotonville

  Influential Leadership and Innovation

• GE Crotonville

  Building Essential Leadership

• GE Crotonville

  Advanced Impact- Business Strategy

• GE Crotonville

  Change Acceleration Process- CAP Coach

• Boston University

  Bachelor of Science

• GE Crotonville

  Lean Six Sigma Greenbelt

Skills

• Corrective and Preventive Action (Capa)
• 21 Cfr Part 11
• Change Management
• Quality Management
• Business Process Improvement
• Fda
• Engineering
• Medical Devices
• Process Engineering
• Agent for Change
• Capa
• Iso 13485
• Iso Standards
• Organizational Change Agent
• Cross-Functional Team Leadership
• Product Design
• Product Development
• Lean Tools
• Project Management
• Root Cause Analysis
• Six Sigma
• Quality Auditing
• U.s. Food and Drug Administration (Fda)
• Design of Experiments
• Manufacturing
• Leadership
• Quality System
• V&V
• Quality Management Systems
• Kaizen
• Lean Six Sigma
• Testing
• Process Validation
• Value Stream Mapping
• Process Improvement
• Asq
• Management