Staff Auditor, Quality Systems- Medical Devices

AbbVie

Minnetonka, Minnesota, United States
Base: $78,000.00 – $156,000.00; bonus/equity: not ...
Quality system auditing
Medical device software auditing
Internal audit planning and execution
Abbott is a global healthcare leader with a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines

Job Summary

  • Abbott is a global healthcare leader with a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines.
  • The role involves leading internal audits, supporting external inspections, and mentoring auditors to improve audit and inspection readiness programs.
  • This position requires collaboration with multiple business units and includes travel up to 50% of the time.

Matching Summary

Abbott is a global healthcare leader with a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines.

Salary

Base: $78,000.00 – $156,000.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Quality system auditing
  • Medical device software auditing
  • Internal audit planning and execution
  • Regulatory compliance with FDA and ISO standards
  • Audit documentation and KPI reporting
  • Travel up to 50%

Nice-to-have

  • Leadership and mentoring skills
  • Project management experience
  • Technical writing and executive reporting
  • Experience with AI in medical devices
  • Inspection readiness support

Key Requirements

  • Bachelor's degree or equivalent experience
  • Minimum 6 years related work experience
  • Strong understanding of FDA 21 CFR Parts 11 & 820 and ISO 13485
  • Lead Auditor certification desirable
  • Experience preparing for FDA or global regulatory inspections

Work Rights

Not specified

Tailored Resume

Cover Letter