QA - IDM 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.

Job Description:

Support the Product Complaint Handling and Medical Device Reporting Processes. This role is designed for an individual who is curious, embraces new digital tools and ways of working, and helps drive practical change across complaint reporting, trending, and stakeholder support.

Specific functions, duties, or tasks:

* Author/review/approve GMP documents including technical reports, deviations, change controls, inspection procedures, process level procedure, and work instructions

* Lead authoring and management of deliverables to support Global Patient Safety and device safety case reporting

* Author regulatory responses and represent Indianapolis Device Manufacturing (IDM) at inspections/audits

* Act as Data Steward for complaint data and ad hoc queries and special issues

* Business owner/SME for new device complaints related systems

* Maintain trend analysis on product and process performance

* Conduct vigilance trending to support potential trend reporting

* Produce and document periodic metrics/ad-hoc reports on process and product performance.

* Collaborate and provide customer service for groups external to IDM, including, but not limited to, manufacturing sites, OUS Affiliates, Global Patient Safety, US Complaint Management, Third Party Manufacturers, Material Suppliers and call centers

* Represent IDM complaints group at cross-functional Device Surveillance activities

* Support continuous improvement projects

* Own, coordinate or participate in project work that requires substantial technical knowledge and continuous improvement skills

* Network within and outside IDM to identify opportunities for improvement and/or transfer IDM best practices to business partners

* Mentor and coach less-experienced QA Representatives and Assistants, as applicable

* Perform notifications to management as required

Minimum Experience/Qualification Requirements:

* Minimum of five years industry related experience in areas, which may include Quality, Technical Services, LRL Product Development, or Manufacturing Operations.

* Bachelor's degree in Engineering, Medical or Life Sciences preferred.

* Technical knowledge in design, manufacturing and validation; preferably device

* Technical knowledge of complaint handling and quality systems; preferably device performance and functionality

* Knowledge of regulatory requirements (e.g., cGMP, 21 CFR 820, ISO
13485, applicable regulations for Canada, US, Europe, Australia, Brazil and Japan)

* Experience with Third party / supplier / consultant interactions

* Excellent oral and written communication

* Working knowledge of statistics and its applications; able to translate data into clear, actionable insights and drive discussion on trends and performance.

* Ability to compile, analyze, and visualize data and metrics into reports understandable by management and business partners; proactively identifies opportunities to standardize, simplify, and automate reporting where appropriate.

* Proficient with Microsoft 365 applications (e.g., Outlook, Word, Excel, PowerPoint).

* Attention to detail;
Self-management;
Problem solving;
Team player;
Mentoring

Additional Preferences:

* Experience with Complaint Processes, IT Tools and Complaint Reporting

* Preferred tech skills: dashboarding/data visualization (e.g., Power BI/Tableau), advanced Excel, basic SQL or similar querying, and experience with electronic quality systems (e.g., Track Wise, Veeva)

* Experience with Six Sigma methodology, e.g., participation on Six Sigma team or project.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

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 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.

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