Principal Associate - Quality Assurance - Device Complaints

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.

In this role individuals will support complaint handling and associated activities for devices, drug/device combination products and Connected Care products as needed.

Key Objectives / Deliverables:

• Review and approve complaint investigations for devices, drug/device combination products, and Connected Care devices and Consumer Electronic Products.  

• Initiate and support Trend analysis, Root Cause Investigations, response to Regulatory authority requests, or other technical investigations, as applicable  

• Perform and document quarterly trend analysis and investigations on product and process performance  

• Compile and document ad-hoc reports, as needed  

• Perform annual evaluation of occurrence/pHarm rankings in support of the post launch risk management process  

• Understand the devices (including connected care devices) and drug/device combination products to support investigations.   

• Support activities associated with device safety surveillance for both devices and drug/device combination products  

• Collaborate, participate in projects, and provide customer service for stakeholders including, but not limited to, Regional Centers, OUS Affiliates, and Global Patient Safety.

• Review/write/approve GMP documents including SOPs, global training, global procedures/non-method procedures, technical reports, and process level procedures and training, as applicable  

• Support continuous improvement projects and new launches as needed  

• Participate in project work that requires substantial technical knowledge and continuous improvement skills  

• Participate in Failure Modes and Effects Analysis (FMEA), as applicable  

• Utilize non-routine software tools or business systems to gather data and provide metrics on device complaint issues or complaint process efficiency  

• Ensure compliance with Medical Device Reporting (MDR) and other regulatory reporting requirements.  

• Support Clinical Trial complaint management by establishing processes for each unique trial, ensuring investigations are completed and approved, performing investigations when needed, and reporting metrics.     

• Assess impact to local and global complaint investigation documents/processes when global documents or systems change and in support of development projects and project launches. Perform gap assessments on local documents when global documents are updated.  

• Network within and outside of department to identify and implement opportunities for improvement and/or transfer of complaint handling best practices to other business partners.  

• Drive product and process improvements through data obtained from complaint trending activities.

Education Requirements:

• Bachelor’s degree required. Degree in Engineering, Medical or Life Sciences preferred.