Senior Consultant - Medtech QMS Complaints
Core
Lead MedTech Complaints implementations and guide the transformation of customers' Complaints Management processes and technology.
Role type
Senior IC software consultant (MedTech Quality Management)
Builds
Cloud-based solutions for managing MedTech Complaints across the enterprise
Domain
Life Sciences / Medical Device / Quality Management Systems
Required skills
Complaints Management in Medical Device, FDA/EU MDR/IVDR regulatory requirements, CAPA/Risk Management processes, ISO 13485/14971 standards, SaaS/GxP principles, Vault platform, process analysis, solution design
Preferred skills
Data or Content Management applications, Life Sciences Quality/Manufacturing/Healthcare experience
Technologies
Vault
Responsibilities
Review and analyze customer business processes to identify gaps and requirements, Lead QMS Complaints implementation workstreams, Function as primary customer liaison, Analyze requirements to develop adoption roadmaps, Guide customers in adopting Vault and industry best practices
Seniority
Senior, hands-on IC
