Eli Lilly and Company
Eli Lilly and Company seeks Principal, QA- IDM (R1 - R4) to define compliance requirements for project teams and participate in identifying specific software deliverables for SaMD (Software as a Medical Device) and SiMD (Software in a Medical Device). Accountable for QA oversight of product development, release, and life cycle management of MMA-mobile medical applications used in digital health. Ensure quality management system compliance by providing input and updates to procedures based on internal and regulatory requirements and drive incident investigations to identify and implement corrective and preventive actions. Ensure development deliverables are complete by conducting phase audits or other audits. Define, implement, and monitor quality design controls for custom developed software and off-the-shelf software management toolsets. Accountable for quality governance and oversight, including change management. #LI-DNI Position requires a Bachelor's degree in Biomedical Engineering, Computer Science, or a related field and 2 years of experience with regulated software and/or firmware commercialization. Experience must include a minimum of: 2 years of experience with risk management using ISO 14971 and ANSI 62304; 2 years of experience with authoring standard operating procedures to standardize design control processes and maintain compliance with ISO 13485; 2 years of experience with performing regulatory compliance reviews and similar auditing; 2 years of experience with design verification and design validation; 2 years of experience with developing and communicating software metrics, including trends, anomalies, requirements testing, and test suite status; 2 years of experience with working with software development teams under multiple product development projects; and 2 years of experience with software product development from concept phase to project closure. Telecommuting benefit available. Up to 10% domestic and international travel required. #LI-DNI Job location: Indianapolis, IN. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-91514 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285.