Qa - Idm Device Complaints

Eli Lilly

Indianapolis, Indiana, United States
Base: $126,000 - $204,600; bonus/equity: eligible ...
Gmp document authoring and approval
Regulatory response and audit representation
Complaint handling and device safety reporting
This role supports global patient safety and medical device reporting processes while driving practical change through digital tools

Job Summary

  • This role supports global patient safety and medical device reporting processes while driving practical change through digital tools.
  • The successful candidate will act as a Data Steward, lead regulatory responses, and represent the company at inspections and audits.
  • Lilly offers a comprehensive benefit program including 401(k), pension, and various well-being benefits alongside competitive compensation.

Matching Summary

This role supports global patient safety and medical device reporting processes while driving practical change through digital tools.

Salary

Base: $126,000 - $204,600; Bonus/Equity: Eligible for company bonus based on performance; Benefits: Comprehensive program including 401(k), pension, medical, dental, vision, and wellness perks

Skills & Requirements

Must-have

  • GMP document authoring and approval
  • Regulatory response and audit representation
  • Complaint handling and device safety reporting
  • Trend analysis on product performance
  • Microsoft 365 proficiency

Nice-to-have

  • Mentoring less-experienced QA staff
  • Continuous improvement project leadership
  • Cross-functional stakeholder collaboration
  • Data visualization and dashboarding skills

Key Requirements

  • Minimum five years industry experience in Quality or Manufacturing
  • Bachelor's degree in Engineering, Medical, or Life Sciences
  • Knowledge of cGMP, 21 CFR 820, and ISO13485 regulations

Work Rights

Not specified

Tailored Resume

Cover Letter