Lead Specialist Quality Assurance
Core
Lead a Quality Analytics function to deliver consistent, high-quality documents, services, products, and processes through advanced data analytics, statistical modeling, and regulatory compliance in the medical device industry.
Role type
Senior IC Quality Analytics Lead (Medical Devices)
Builds
Quality dashboards, automated reports, and predictive analytics solutions for regulatory compliance and risk reduction.
Domain
Medical Devices / Quality Assurance / Data Science
Deliverable
production ML models
Required skills
Python, R, SQL, SAS, Machine Learning, Predictive Analytics, Statistical Analysis, Power BI, Data Visualization, Regulatory Compliance (FDA 21 CFR Part 820, ISO 13485), Data Governance
Preferred skills
Data Science, Biostatistics, Computer Science, Engineering, Mathematics, Quality Engineering
Technologies
Python, R, SQL, SAS, Power BI, Infinity QS
Responsibilities
Execute advanced quality data analytics and investigations; Lead cross-functional data-driven initiatives for quality improvement; Analyze complex datasets from CAPA, Complaints, and Post-Market Surveillance systems; Design and maintain dashboards and automated reports; Mentor analysts and quality professionals; Collaborate with Quality, Operations, Engineering, and Regulatory teams; Support regulatory inspections and CAPA assessments.
Seniority
Senior, hands-on IC with leadership responsibilities