Senior Quality Analyst (Based in São Paulo)
Core
Ensures integrity and safety of medical device/pharmaceutical products through quality systems, post-market surveillance, and regulatory compliance.
Role type
Senior Quality Analyst (Medical Device/Pharma)
Builds
Quality systems, compliance processes, and post-market safety communications
Domain
Medical Device / Pharmaceutical / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Quality systems management, post-market surveillance, complaint handling, regulatory compliance, data analysis, process improvement, audit coordination, training development
Preferred skills
Medical device industry experience, Latin American regulatory knowledge, stakeholder collaboration
Technologies
Quality management systems, complaint tracking tools, data analysis platforms
Responsibilities
Manage field actions and post-integration regulatory transitions; lead business process improvement initiatives for Quality Systems; manage post-market surveillance and customer complaint investigations; prepare customer response communications; analyze quality metrics and trends; support corrective actions, recalls, and alerts; assist with internal and supplier audits; develop and deliver training programs.
Seniority
Senior, hands-on IC with leadership potential
