Senior Consultant - Medtech QMS Complaints

📋 Description

• Lead QMS Complaints implementation workstreams for MedTech Quality Management solutions
• Review and analyze customer processes to identify gaps and requirements for implementation
• Serve as primary liaison between implementation teams, customers, and 3rd parties
• Analyze requirements and features to develop adoption roadmaps
• Guide post-implementation optimization with Vault and industry best practices

🎯 Requirements

• Proven track record leading implementation or IT operations as consultant, analyst, or IT lead
• 5+ years in Complaints Management for Medical Device
• Strong understanding of FDA, EU MDR/IVDR requirements and Reporting
• Knowledge of Complaint Handling, CAPA, Nonconformance and Risk Management
• Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11
• Ability to work independently and in teams in dynamic environments