Principal Associate QA - IDM (R3 – R4)

Eli Lilly and Company • Indianapolis, IN

2d • Hybrid

About The Position

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 a Principal Associate QA - IDM (R3 – R4) to provide quality oversight and support for medical devices and combination products during technical transfer to contract manufacturing operations. Ensure design meets critical requirements and risks to product quality have been identified, addressed in the design and tested. 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. #LI-DNI Position requires a Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related field and 5 years of progressively responsible experience in Quality, Technical Services, Product Development, and/or Manufacturing of medical devices. Experience must include a minimum of: 5 years of experience with 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); 5 years of experience with Quality System elements, devices, design, manufacturing, and validation and their application in a manufacturing environment; 5 years of experience with plastic molding/assembly operations; 5 years of experience with Microsoft applications, Veeva, and TrackWise. Up to 25% domestic travel required. Part-time telecommuting may be permitted. #LI-DNI Job location: Indianapolis, IN. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-103491 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 $124,200.00 per year 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. #WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly

Requirements

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related field
• 5 years of progressively responsible experience in Quality, Technical Services, Product Development, and/or Manufacturing of medical devices.
• 5 years of experience with 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)
• 5 years of experience with Quality System elements, devices, design, manufacturing, and validation and their application in a manufacturing environment
• 5 years of experience with plastic molding/assembly operations
• 5 years of experience with Microsoft applications, Veeva, and TrackWise

Responsibilities

• Provide quality oversight and support for medical devices and combination products during technical transfer to contract manufacturing operations.
• Ensure design meets critical requirements and risks to product quality have been identified, addressed in the design and tested.
• 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.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees