Associate Director - QA - Medical Device Complaints

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.

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 objectives
• Review and approve complaint investigations associated with use, design, and manufacturing investigations for medical devices and drug/device combination products
• Maintain key product and process metrics reporting the performance of the quality system to management with executive responsibility and ensure timely escalations when necessary
• Drive product and process improvements using Root Cause Investigations, Complaint Actions, Trends, and Review Management
• Network within and outside of Lilly device organization to identify and implement opportunities for improvement and/or transfer of complaint handling Best Practices
• Review / write / approve GMP documents including technical reports, deviations/observations, procedures, and work instructions
• Collaborate 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 teams
• Ensure that adequately trained personnel and approved procedures and resources are available locally and used for the completion of complaint investigations
• Support complaint related activities associated with new product launches
• Support 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 Sciences
• 5+ 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 reporting
• Technical knowledge in design, manufacturing or validation; preferably devices
• Technical knowledge of complaint handling and quality systems; preferably devices performance
• Regulatory inspection experience
• Knowledge 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/consultants
• Experience with Six Sigma methodology, e.g., participation on Six Sigma projects
• preferably experience working with medical devices
• Leadership ability and experience with multi-functional teams
• Excellent oral and written communication
• Basic knowledge in statistics and its applications
• Ability to compile data and metrics in reports understandable by management and business partners
• Strong computer literacy in Microsoft applications
• Attention 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 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 an