Global Device QA: Complaints & Data Insights Lead

Eli Lilly and Company; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off and leave

Well-being programs

Job summary

Eli Lilly and Company in Indianapolis, Indiana, seeks a Quality Assurance Specialist - Device Complaints to safeguard patient safety and product quality through rigorous complaint handling, surveillance, and regulatory reporting.

You will lead global device complaint reporting, analyze trends, build dashboards, and drive improvements across GMP documentation, CAPAs, and change controls while partnering with manufacturing, suppliers, and Patient Safety teams.

Qualifications

• 5+ years in Quality, Manufacturing, or Technical Services (device preferred)
• Bachelor's degree in Engineering, Life Sciences, or related
• Experience with complaint handling and quality systems
• Knowledge of cGMP, 21 CFR 820, ISO 13485, and global regulations
• Strong data analysis and reporting skills
• Basic statistics knowledge
• Proficient in Microsoft 365 (Excel, Word, PowerPoint)

Responsibilities

• Lead Global Patient Safety and device complaint reporting
• Own complaint data, investigations, and system support
• Author regulatory responses and support audits/inspections
• Analyze complaint trends and product performance
• Build reports/dashboards and deliver actionable insights
• Improve and automate reporting processes
• Author/review GMP documentation (deviations, CAPA, change control, SOPs)
• Partner with manufacturing, global teams, suppliers, and Patient Safety
• Support device surveillance activities
• Mentor junior QA team members
• Lead or support process improvement initiatives
• Drive best practices across complaint handling and reporting

Skills

Quality assurance

Data analysis

cGMP knowledge

Regulatory reporting

Excel/Office 365

Statistics basics

Power BI/Tableau

SQL (plus)

Education

Bachelor's degree in Engineering/Life Sciences

Tools

TrackWise

Veeva

Power BI

Tableau

SQL

Job description

Eli Lilly and Company in Indianapolis, Indiana, seeks a Quality Assurance Specialist - Device Complaints to safeguard patient safety and product quality through rigorous complaint handling, surveillance, and regulatory reporting.

You will lead global device complaint reporting, analyze trends, build dashboards, and drive improvements across GMP documentation, CAPAs, and change controls while partnering with manufacturing, suppliers, and Patient Safety teams.