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 - $204,600Full-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
Skills Required
- Minimum of five years industry related experience in Quality, Technical Services, Product Development, or Manufacturing Operations
- Bachelor's degree in Engineering, Medical or Life Sciences
- Technical knowledge in design, manufacturing and validation (preferably device)
- Technical knowledge of complaint handling and quality systems (device performance and functionality preferred)
- Knowledge of regulatory requirements (cGMP, 21 CFR 820, ISO 13485 and applicable global regulations)
- Experience interacting with third parties, suppliers, and consultants
- Excellent oral and written communication skills
- Working knowledge of statistics and ability to translate data into actionable insights
- Ability to compile, analyze, visualize data and metrics for management; standardize and automate reporting
- Proficient with Microsoft 365 applications (Outlook, Word, Excel, PowerPoint)
- Attention to detail, self-management, problem solving, team player, mentoring experience
- Experience with complaint processes, IT tools, and complaint reporting
- Dashboarding/data visualization (Power BI/Tableau), advanced Excel, basic SQL or similar querying, electronic quality systems (TrackWise, Veeva)
- Experience with Six Sigma methodology or participation on Six Sigma projects
Eli Lilly and Company Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Eli Lilly and Company and has not been reviewed or approved by Eli Lilly and Company.
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Retirement Support — Feedback suggests long-term savings are bolstered by a defined-benefit pension alongside a company 401(k) match and retiree health options. These elements make total compensation feel strong beyond base salary.
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Leave & Time Off Breadth — Feedback suggests paid time off is expansive, with substantial vacation, company shutdown days, and milestone time. This breadth of leave is viewed as a meaningful part of overall rewards.
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Parental & Family Support — Feedback suggests family-building and caregiving support are robust, including paid parental leave, adoption or surrogacy assistance, and backup care. These programs enhance the perceived value of benefits across life stages.
Eli Lilly and Company Insights
What We Do
Eli Lilly and Company engages in the discovery, development, manufacture, and sale of products in pharmaceutical products business segment. For more than a century, we have stayed true to a core set of values – excellence, integrity, and respect for people – that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.
