Staff Auditor, Quality Systems- Medical Devices

AbbVie

Minnetonka, Minnesota, United States
Base: $78,000.00 – $156,000.00; bonus/equity: not ...
Medical device and software auditing
Internal audit planning and execution
Regulatory compliance (fda, iso 13485)
Support internal audit programs required for compliance with global regulatory standards and collaborate with Abbott Medical Device Business Units for external inspection preparation and support

Job Summary

  • Support internal audit programs required for compliance with global regulatory standards and collaborate with Abbott Medical Device Business Units for external inspection preparation and support.
  • Lead the planning, development, and implementation of internal audit schedules and risk-based audit plans, specifically incorporating software lifecycle and validation requirements.
  • Provide leadership, oversight, and project management covering external inspections as related to Abbott's Quality System, including division/business support, quality/regulation expertise, and consulting activities.

Matching Summary

Support internal audit programs required for compliance with global regulatory standards and collaborate with Abbott Medical Device Business Units for external inspection preparation and support.

Salary

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

Skills & Requirements

Must-have

  • Medical device and software auditing
  • Internal audit planning and execution
  • Regulatory compliance (FDA, ISO 13485)
  • Software lifecycle and validation
  • Risk management (ISO 14971)
  • Technical documentation assessment

Nice-to-have

  • Inspection readiness support
  • Mentoring and leadership skills
  • Cross-functional project management
  • Executive-level reporting

Key Requirements

  • Minimum 6 years related work experience
  • Bachelors Degree (± 16 years) or equivalent
  • Masters Degree (± 18 years) preferred
  • Lead Auditor certification desirable
  • Ability to travel 25–50%

Work Rights

Not specified

Tailored Resume

Cover Letter