QA - IDM Device Complaints

Lilly • Indianapolis, IN

7d • $126,000 - $204,600 • Onsite

About The Position

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.

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, ISO13485, 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

Nice To Haves

• 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., TrackWise, Veeva)
• Experience with Six Sigma methodology, e.g., participation on Six Sigma team or project.

Responsibilities

• 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

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level