Quality Assurance Specialist - Device Complaints, IDM

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 (Track Wise, 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 (  ) 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…