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

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