QA Device

2 weeks ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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.

Delivery Device and Connected Solutions (DDCS) and Indianapolis Device Manufacturing (IDM) leads all aspects of the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly's portfolio. The QA Representative - Commissioning and Qualification provides quality oversight and support for medical devices and combination products during technical transfer to contract manufacturing operations.

Responsibilities:

The quality representative ensures design meets critical requirements and risks to product quality have been identified, addressed in the design and tested. The quality representative will verify that equipment is fit for use and ensure manufacturing readiness for prospective contract manufacturers (CM) and suppliers. Provide quality oversight for the technical transfer of medical devices in the emerging IDM portfolio. Support device development reviews to ensure appropriate design for manufacturability. Conduct manufacturing readiness assessments for prospective contract manufacturers and suppliers to ensure adequacy of the Quality Management System (e.g., facility, staffing, procedures, training, maintenance). Provide quality support/consulting for TS/MS device manufacturing for design verification, molding packages, process validation (component, non-molded component, subassembly, final pen) and change control including equipment modifications. Review/approve GMP documents for CMs process manufacturing including: protocols, technical reports, deviations, change controls, inspection procedures and specifications, sampling plans, sort/rework procedures and validation packages. Support continuous improvement projects. Assist with internal audits and supplier audits and maintain supplier management requirements. Computer system validation activities, serving as CSQA (Computer Systems Qualified Associate) for review and approvals. Provide CM Q support for newly launched products as requested by manager. Apply knowledge of medical device governing standards and regulations (e.g., 21 CFR Part 4, Part 11, Parts 210/211, Part 820, QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical Device Directive, JPAL) to ensure organizational capability of prospective contract manufacturers and suppliers. Basic Qualifications: 5+ years industry related experience which may include Quality, Technical Services, Product Development, and/or Manufacturing of medical devices preferred Bachelor's Degree in engineering or science related field preferred Additional Skills/Preferences: 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) Knowledge of Quality System elements, devices, design, manufacturing, and validation and their application in a manufacturing environment Experience with plastic molding/assembly operations Experience with Microsoft applications, Veeva, TrackWise Effective communication, interpersonal, and networking skill Self-management skills Strong attention to detail Ability to work as part of a team Problem solving skills Meets commitments and deadlines Ability to multi-task meaningful priorities Strong technical writing skills and proficiency in technical review of documents Strong organizational, time management and planning skills Ability to work in a dynamic, highly matrixed and fast paced environment Additional Information: Some US and OUS travel may be required (approximately 0-10%) 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 ( ) 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. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly

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