Complaint Process Owner Connected Care

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Job description

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.

This position is within the IDM (Indianapolis Device Manufacturing) Quality team and will implement and support complaint handling processes and interfaces to design and change control processes and associated activities for connected medical devices and drug/device combination products (Connected Care Systems and MMAs (Mobile Medical Applications .

Key Objectives/ Deliverables:

• To establish and maintain a Quality and contractual system with external service providers to provide front line customer support and execute technical troubleshooting and complaint investigations for Lilly's connected devices.

• To provide Quality oversight for quality system activities performed by external contract service providers.

• To lead implementation and maintenance of the customer support and quality system for connected devices and stand-alone SaMD (Software as Medical Device).

• To drive product and process improvements through data obtained through complaint trending activities.

• To review/write/approve GMP documents including technical reports, deviations/events, procedures, and work instructions.

• To review and approve complaint investigations associated with use, design, contract manufacturing investigations for connected devices and drug/device combination products.

• Lead onboarding and training of contract partners and implementation of connected product complaint process. Mentor, coach and provide feedback to external contract partners including participation in organizational planning.

• Maintain key product and process metrics reporting the performance of the connected device customer support quality system to management with executive responsibility.

• Network within and outside of IDM to identify and implement opportunities for improvement and/or transfer of IDM or complaint handling Best Practices for connected products to other business partners.

• Collaborate with and provide customer service for groups external to IDM. Participate in meetings and teleconferences with Contract Partners, US and OUS Affiliates, Global Patient Safety, Americas' Regional Center, DPEM, Material Suppliers, and TLAC/external customer service providers, as applicable, to share technical and complaint process knowledge and to support investigations as needed.

• Participate in or lead collaborative projects between the Complaint Regional Centers, Lilly Affiliates, Global Patient Safety, TLAC, and external contract partners. Implement applicable requirement from LQS, GQS, SEQS, CIQS quality policies for connected products. Ensure compliance with Medical Device Reporting (MDR) requirements for connected products.

• Provide internal and external contracted complaint and customer service centers with complaint investigation procedures and Training/Knowledge Assessments for all connected devices as required in support of an established complaint triage strategy

Minimum Requirements:

• Bachelor's Degree required.

• Minimum of two years of life science, engineering or related industry experience in areas which may include Quality , MS&T, LRL, Development or Manufacturing/Packaging, Technical Customer Service, or Change Management. Experience with connected products would be an additional benefit.

• Technical knowledge in design, manufacturing, or validation in the area of medical devices or combination products.

• Technical knowledge of complaint handling and associated quality systems; preferably electronic and/or connected devices performance; technical knowledge/experience with medical device risk management

Additional Skills/Preferences:

• Demonstrated leadership ability and experience with cross functional teams

• Knowledge of applicable regulatory requirements (e.g. cGMP, 21 CFR 820, ISO13485 , ISO14971, applicable regulations for Canada, US, EU, Australia, Brazil and Japan)

• Experience with external parties/supplier/consultant interactions

• 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 technical GMP compliant computer systems and Microsoft Office 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 ( ) 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.

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