Sr. Quality Specialist – Post Market & Supplier Quality
Core
Leads projects to resolve complex quality and compliance issues, manages supplier quality processes, and ensures adherence to global regulatory standards for medical devices.
Role type
Senior IC Quality Specialist (Post Market & Supplier Quality)
Builds
Regulatory submissions (MDRs, vigilance reports), supplier qualification processes, and quality system improvements.
Domain
Medical Devices / Healthcare Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance analysis, supplier risk assessment, CAPA management, audit execution, statistical analysis, problem-solving, cross-functional leadership, documentation management
Preferred skills
Knowledge of ISO 13485, FDA QSR, MDR/IVDR regulations, software compliance (21 CFR Part 11), consumer regulations
Technologies
Databases, computer software, regulatory reporting systems
Responsibilities
Review complaints for regulatory compliance and patient safety impact; establish regulatory reportability decisions; own supplier onboarding and qualification processes; write Medical Device Reports and vigilance reports; lead cross-functional quality system process improvements; complete documentation in accordance with business standards
Seniority
Senior, hands-on IC