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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.

Job Title:** **Associate Director – Device Development QA

Organization Overview:

The Associate Director - Device Development QA position is responsible for managing a team of Quality Professionals providing Quality oversight of medical device and combination product development projects from proof-of-concept through launch. This individual should be versed in operating in a tightly regulated environment, but capable to apply regulations as phase appropriate and to consult and make Quality decisions in “grey” areas, as well as have experience with the application of Device Design Controls.

Responsibilities:

+ Managing a team of Quality Professionals who provide Quality support for product development teams related to medical device/combination product design control from Advanced Development/Proof of Concept through Launch.

+ Coach and oversee the development of direct reports and participate in business and succession planning.

+ Support the Secretary of the Device Safety Lead Team (DSLT) with meeting management, follow up actions and document approval.

+ Influence and support teams, alliance partners, and Contract Manufacturers on Quality Systems.

+ Consult, influence, and drive improvements of the Design Control Quality System and Design History File requirements.

+ Quality support of clinical trial lot release process.

+ Review/approve documents including protocols, technical reports, deviations, change controls, inspection procedures, specifications, drawings, sampling plans, and validation packages.

+ Review of Risk Management Activities including Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), System Risk Analysis (SRA) and/or Safety Assurance Cases.

+ Support continuous improvement projects.

+ Assist with internal audits and supplier audits (including due diligence) and maintain supplier development partnerships.

+ Consult/work with Regulatory to assure compliance with applicable registrations, standards, guidance and requirements.

+ Support of Quality System initiatives (periodic reviews, self-assessments, CAPA, Development Quality Agreements, etc.) as needed.

+ Manage Global Quality Standards related to design control of medical devices, including periodic review.

Basic Requirements:

+ Bachelor’s degree in scientific discipline

+ 3-5 years of experience in regulated device environment

Additional Skills/Preferences:

+ Technical knowledge in medical device, primary/secondary packaging, or drug development.

+ Experience with Design Controls

+ Working knowledge of drug or device quality systems.

+ Technical knowledge of regulatory requirements (e.g. 21 CFR Parts 210, 211, and 820, ISO 13485, Medical Device Directive/EU MDR, applicable medical device regulations for Canada, US, Australia, Brazil and Japan).

+ Experience in risk management tools, in particular ISO14971 and related standards.

+ Experience with Human Factors

+ Basic knowledge in statistics and its application.

+ Demonstrated interpersonal skills with internal and external partners.

Additional Information:

+ Location is at Lilly Technology Center – North, in Indianapolis.

+ Approx. 10 % Business Travel required.

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

$123,000 - $180,400

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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