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.

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. RATE OF PAY: $113,232.00 per year.

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.

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

Full-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.

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