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