QA Associate - IDM 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.

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.

Organization Overview:

The Indianapolis Device Manufacturing (IDM) Complaints Quality Assurance (QA) organization is responsible for IDM's device and drug/device combination product complaint handling process. The QA Associate's main responsibilities include approving complaint investigations, compiling and analyzing complaint data, collaborating with internal teams to support existing and new products, creating and conducting training, supporting internal and external audits, and supporting the post launch risk management process.

Responsibilities:

• Review and approve complaint investigations for devices, drug/device combination products, Mobile Medical Applications (MMAs), and Connected Care devices.
• Initiate and support Trackwise Trends, Root Cause Investigations, Review Management, Changes, Deviations, and/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.
• Perform annual evaluation of occurrence/pHarm rankings in support of the post launch risk management process.
• Understand the devices (including Connected Care devices), MMAs and drug/device combination products to support investigations as defined in associated global and local complaint handling procedures.
• Support activities associated with device safety surveillance for both devices and drug/device combination products.
• Collaborate in projects, and provide customer service for groups external to IDM, including, but not limited to, Regional Centers, OUS Affiliates, Global Patient Safety, Drug Product External Manufacturing and contract manufacturing suppliers.
• Review / write / approve GMP documents including SOPs, global training, global procedures/non-method procedures, technical reports, and process level procedures and training.
• Support continuous improvement projects and new product launches, as applicable.
• Assist in project work that requires meaningful technical knowledge and continuous improvement skills.
• Assist in Failure Modes and Effects Analysis (FMEA), as applicable.
• Use non-routine software tools or business systems to gather data and provide metrics on device complaint issues or complaint process efficiencies.
• 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 and processes when global documents or systems change. 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 handling best practices to other business partners.
• Drive product and process improvements using data acquired through complaint trending activities.

Basic Qualifications:

• Bachelor’s degree preferred; degree in Engineering, Medical or Life Sciences preferred.
• Minimum of three years' experience in areas which may include Quality, MS&T, LRL, Development or Manufacturing/Packaging required.
• Technical knowledge in device design, manufacturing or validation preferred.
• Technical knowledge of device complaint handling and/or quality systems preferred.
• Knowledge of regulatory requirements (e.g. cGMP, 21 CFR 820, ISO 13485, Canadian MDR, etc.) preferred.
• Strong technical literacy in Outlook and Microsoft Office preferred.

Additional Skills/Preferences:

• Basic knowledge in statistics and its applications.
• Ability to compile da