Avi Kluger

About Avi Kluger

Experienced Management Professional with Broad Expertise in Compliance and OperationsDecisive, results-generating leader offering expertise in compliance, regulatory affairs, quality systems, project management, customer-focused operations and global operations roles. Experience managing process improvement and process change initiatives that have contributed directly to the bottom line, improved quality, and lowered compliance risk. Successful track record of creating and implementing global customer-focused business processes and systems, developing, motivating and engaging employees, and managing critical compliance and quality projects. Areas of expertise:Compliance • Quality • Regulatory Affairs • Operations Management • Process Development and Change Implementation • Capacity Planning • International Distribution and Logistics • Budget Management • Global Supply Chain Management • Personnel Management • Performing Internal Compliance Audits • Front Room Compliance Audit Experience (FDA, TUV, UL, etc.) • Cross-functional Project Management • CAPA (Corrective and Preventive Action) • Collaboration and Consultation with Legal Counsel on Litigation and Government Affairs • Corporate Process Standardization • Root-Cause Analysis

Experience

1. Sr Customer Quality Process Manager

   Medtronic

   Dec 2021 — Present · Boulder, CO, US

   Responsible to execute on Customer Quality (CQ) strategy, establish standards, and lead a strong team of experts to provide centralized services for the global, enterprise wide CQ organization in the areas of: Process, Audit, CAPA, Compliance, Training, and QMS.

Education

• University of Colorado Boulder

  Bachelor of Arts (BA), Political Science

  1996 — 2001

• University of Colorado Boulder

  BA, Political Science

  1996 — 2001

Skills

• Logistics
• Quality Assurance
• Process Management
• Customer Relations
• Compliance
• Supply Chain Management
• Fda
• International Logistics
• Export Documentation
• Letters of Credit
• Budget Management
• Complaint Handling
• Capa
• Complaint Management
• Medical Devices
• Cross-Functional Team Leadership
• Supply Chain
• Customer Service
• Product Launch
• Market Development
• U.s. Food and Drug Administration (Fda)
• Budgets
• Corrective and Preventive Action (Capa)
• Management
• Documentations
• Leadership
• Business Process Improvement
• Sap Implementation
• Sap Erp
• Salesforce.com
• Employee Training
• Training Course Development
• Acquisition Integration
• Sop Development
• Risk Management
• Risk Assessment
• Patient Safety
• Strategy
• Project Management
• Change Management