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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$118,500 - $173,800

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 35,000 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.

The Associate Director will provide management oversight for quality system activities performed by Quality Assurance in the medical device complaint handling area. To support implementation and maintenance of the complaint handling elements of the quality system for devices and drug/device combination products.

Responsibilities:

Lead, mentor, coach and provide feedback to employees including participation in organizational planning, HR activities, financial management, and diversity objectivesReview and approve complaint investigations associated with use, design, and manufacturing investigations for medical devices and drug/device combination productsMaintain key product and process metrics reporting the performance of the quality system to management with executive responsibility and ensure timely escalations when necessaryDrive product and process improvements using Root Cause Investigations, Complaint Actions, Trends, and Review ManagementNetwork within and outside of Lilly device organization to identify and implement opportunities for improvement and/or transfer of complaint handling Best PracticesReview / write / approve GMP documents including technical reports, deviations/observations, procedures, and work instructionsCollaborate and provide customer service for groups across Lilly. Share technical and complaint process knowledge and support investigations as needed.Support projects as part of cross functional Lilly teamsEnsure that adequately trained personnel and approved procedures and resources are available locally and used for the completion of complaint investigationsSupport complaint related activities associated with new product launchesSupport device development processes by providing complaint analyses of predicate products as design input and by supporting complaint handling activities for clinical trials.Assist with and respond to internal and external audits/inspections

Basic Qualifications:

Bachelor’s degree in Engineering, Medical or Life Sciences5+ years of industry experience in areas including Quality, Technical Services, Research and Development or Manufacturing/Packaging.

Additional Preferences:

Experiences with Complaint processes, IT tools, and reportingTechnical knowledge in design, manufacturing or validation; preferably devicesTechnical knowledge of complaint handling and quality systems; preferably devices performanceRegulatory inspection experienceKnowledge of regulatory requirements (e.g., cGMP, 21 CFR 820, ISO13485, applicable regulations for Canada, US, Australia, Brazil and Japan)Experience partnering with external parties/supplier/consultantsExperience with Six Sigma methodology, e.g., participation on Six Sigma projectspreferably experience working with medical devicesLeadership ability and experience with multi-functional teamsExcellent oral and written communicationBasic knowledge in statistics and its applicationsAbility to compile data and metrics in reports understandable by management and business partnersStrong computer literacy in Microsoft applicationsAttention to detail; self-management; problem solving; mentoring

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 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.

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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