Job Information
Lilly Quality Assurance Complaints Associate in Indianapolis, Indiana
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 35,000 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.
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Brand Description:
The Quality Assurance Complaints Associate provides oversight and support to complaint handling process of medical devices and combination products for Indianapolis Device Manufacturing (IDM). The primary responsibility is to oversee the quality of complaint investigations, support device surveillance activities, and ensure compliance to medical reporting requirements. Additionally, the Sr. Associate provides assistance and guidance on quality defect investigations, CAPA, change control, and audits.
Responsibilities:
Review and approve complaint investigations for devices, drug/device combination products.
Initiate and support Trends, Root Cause Investigations, Review Management, Change, Deviation, 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
Support of the post launch risk management process.
Understand the devices to support investigations as defined in associated complaint procedures.
Support activities associated with device safety surveillance for both devices and drug/device combination products.
Collaborate, participate in projects, and provide customer service for groups external to IDM.
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.
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 IDM to identify and implement opportunities for improvement and/or transfer of IDM or complaint handled best practices to other business partners.
Drive product and process improvements through data obtained through complaint trending activities.
Basic Requirements:
Bachelor’s Degree in science related field
Minimum of three years experience in regulated industry
Technical knowledge in design, manufacturing or validation
Additional Preferences:
Knowledge of Quality System elements and their application in a manufacturing environment
Experience with plastic molding/assembly operations
Experience with Microsoft applications, Trackwise, QualityDocs
Experience working with contract manufacturers and suppliers
Knowledge of global medical devices and combination product regulations (e.g. 21CFR820, 21CFR Part 4, Part 11, ISO 13485, ISO 11608, Canadian MDR, EU Medical Devices Directive/Regulation, JPAL, TGA, ANVISA)
Strong computer literacy in Excel and other Microsoft applications
Ability to work in a dynamic and fast-paced environment
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).