Senior Consultant - MedTech QMS

📋 Description Review and analyze existing Customer business process and identify key process steps, gaps, and Lead QMS Complaints implementation workstreams at our customers for Veeva’s MedTech Quality Function as a Primary customer liaison managing communication between implementation teams Analyze customer requirements and new product features to develop customer adoption and enhancement Guide customers in adopting Vault and industry best practices as part of post-implementation 🎯 Requirements 8+ years of experience in GMP Systems ownership or Software Consulting 5+ years of experience in Complaints Management for Medical Device Strong understanding of FDA, EU MDR/IVDR requirements and Reporting Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven track record leading implementation and/or IT operations as a consultant, business analyst 🎁 Benefits Medical, dental, vision, and basic life insurance Flexible PTO and company paid holidays Retirement programs 1% charitable giving program