Senior Consultant - MedTech QMS

Job Summary

A company is looking for a Senior Consultant - MedTech QMS Complaints.

Key Responsibilities

• Review and analyze existing customer business processes to identify key steps, gaps, and requirements for implementation
• Lead QMS Complaints implementation workstreams for MedTech Quality Management solutions
• Act as the primary customer liaison, managing communication between implementation teams, customer stakeholders, and third parties

Required Qualifications

• 8+ years of experience in Project Management, GMP Systems ownership, or Software Consulting
• 4+ years of experience in Complaints Management for Medical Devices
• Strong understanding of FDA, EU MDR/IVDR requirements, and Reporting
• Knowledge of ISO 13485 and 14971, FDA regulations, and EU GMP Annex 11
• Proven track record in leading implementation or IT operations as a consultant or business analyst