Sr QA Post Market Data Analyst

Integrated DNA Technologies (IDT), a Danaher operating company, develops genomics solutions that help researchers advance life-changing scientific discoveries. The Senior Quality Engineer – Post Market Data Analyst transforms post-market surveillance and complaint-handling data into actionable insights, develops business intelligence solutions, identifies quality trends, and supports data-driven quality, safety, compliance, and continuous improvement initiatives.

Responsibilities:

• Develop, maintain, and automate Power BI dashboards and reports that provide visibility into complaint trends, closure rates, aging metrics, and risk indicators
• Perform advanced statistical analyses using quality engineering tools and methodologies to identify emerging signals, recurring issues, and systemic risks
• Generate and communicate trend reports and quality metrics to support Quality Management Reviews (QMRs), CAPA programs, management reviews, and regulatory submissions
• Ensure integrity, accuracy, and governance of complaint data through validation, reconciliation, and continuous monitoring processes
• Partner with Complaint Analysts, Quality Engineers, Regulatory Affairs, IT, Product Development, and Manufacturing teams to investigate quality issues and support corrective and preventive actions

Requirements:

• Bachelor's degree in Engineering, Data Science, Statistics, Quality Engineering, or a related technical field
• 5+ years of experience in quality engineering, quality systems, or post-market surveillance with a strong focus on data analytics and reporting
• Working knowledge of ISO 13485, 21 CFR Part 820, 21 CFR Part 803, Quality System Regulations, and medical device or IVD quality requirements
• Experience developing dashboards and reports using Power BI and advanced data analysis tools
• Proficiency with SQL, Excel, and statistical analysis software such as Minitab, JMP, R, or Python
• Master's degree in Engineering, Data Science, Statistics, or a related discipline
• Experience within regulated industries such as medical devices, biotechnology, pharmaceuticals, or aerospace
• Six Sigma Green Belt, Black Belt, Certified Quality Engineer (CQE), or equivalent quality certification