Senior Quality Specialist
Core
Lead complex quality and regulatory initiatives impacting patient safety, compliance, and business operations for medical devices.
Role type
Senior Quality Specialist (Regulatory & Supplier Quality)
Builds
Regulatory submissions (MDRs, MedWatch, Vigilance), supplier quality assurance, and quality system effectiveness.
Domain
Medical Devices / Healthcare / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory reporting (MDR, MedWatch, Vigilance), Supplier quality management, Quality system compliance (ISO 13485, FDA QSR), Root cause analysis, Cross-functional leadership, Project management, Risk assessment, Statistical analysis, CAPA management
Preferred skills
Knowledge of consumer regulations, Software compliance (21 CFR Part 11), Design control activities
Technologies
Databases, Computer software
Responsibilities
Lead complaint assessments and regulatory reporting decisions; Drive supplier quality activities including qualification and risk assessment; Write and transmit regulatory reports to authorities; Lead cross-functional alignment on quality system process improvements; Complete documentation in accordance with business standards.
Seniority
Senior, hands-on IC with leadership exposure