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Updated 2026-06-10 18:00 UTC·© 2025–2026 RoleSuite
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Quality Assurance Specialist - Device Complaints, IDM

Eli Lilly · US, Indianapolis IN

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.

What You’ll Do

Complaint Handling & Reporting

  • Lead Global Patient Safety and device complaint reporting
  • Own complaint data, investigations, and system support
  • Author regulatory responses and support audits/inspections

Trending & Insights

  • Analyze complaint trends and product performance
  • Build reports/dashboards and deliver actionable insights
  • Improve and automate reporting processes

Quality Systems

  • Author/review GMP documentation (deviations, CAPA, change control, SOPs)

Collaboration

  • 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)

Preferred Qualifications

  • 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 dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.


Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

QA & Testing pay context

Based on 756 disclosed QA & Testing salaries on RoleSuite, the role pays a median of $122K/year, with most offers between $98K and $161K (10th–90th percentile: $82K–$200K).

This posting lists $126K–$205K, above the $122K market median.

See the full QA & Testing salary breakdown →
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