Post Market Complaints Data Analyst
Core
End-to-end delivery and governance of post-market surveillance (PMS) and complaint data analytics to ensure regulatory compliance and support business decision-making.
Role type
Senior IC data analyst (medical device quality)
Builds
Centralized BI reporting dashboards, data models, and automated reporting processes for complaint trending and signal detection.
Domain
Medical device industry + Post-market surveillance and quality engineering
Deliverable
dashboards & analysis
Required skills
Power BI, Excel (advanced), Minitab, SQL, Azure/Fabric, data extraction and transformation, statistical analysis, root cause analysis, regulatory compliance knowledge (EU MDR, 21 CFR 820, ISO 13485, ISO 14971)
Preferred skills
Six Sigma Green/Black Belt, Quality Management System certification (ISO 13485, ISO 9001, ASQ), AI-based PMS analysis experience
Technologies
Power BI, Excel, Minitab, SQL, Azure, Fabric
Responsibilities
Develop and maintain centralized BI dashboards aggregating complaint data across business units; extract, clean, and validate complaint data from multiple systems; analyze data to detect emerging trends and quality issues; support CAPAs, Health Hazard Evaluations, and design control activities; present trend analyses and support root cause investigations; automate reporting processes; lead training for non-technical users on Power BI models.
Seniority
Senior, hands-on IC