Partner with manufacturing, global teams, suppliers, and Patient Safety
Support device surveillance activities
Mentor junior QA team members
Continuous Improvement
Lead or support process improvement initiatives
Drive best practices across complaint handling and reporting
Required Qualifications
5+ years in Quality, Manufacturing, or Technical Services (device preferred)
Bachelor's degree (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)
Requirements
eQMS experience (TrackWise, Veeva, etc.)
Power BI / Tableau / data visualization skills
Advanced Excel; SQL a plus
Six Sigma or continuous improvement experience
Supplier or third-party manufacturing experience
Work Authorization
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offFlexible schedulePerformance bonus
Additional Information
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The Quality Assurance Specialist - Device Complaints plays a critical role in protecting product quality and patient safety by ensuring complaint handling, surveillance, and regulatory reporting processes are executed with precision and continuously improved.
This position is ideal for a quality professional who combines strong GMP and medical device fundamentals with a data-driven mindset-someone who can translate complaint trends into actionable insights, enhance reporting capabilities, and serve as a trusted partner across global quality and manufacturing teams.
Eli Lilly · Indianapolis IN