Abbott Laboratories

Senior Software Risk and Compliance Auditor

Abbott Laboratories(1 month ago)

United States, Illinois, Abbott Park, ILOnsiteFull TimeSenior$129,300 - $258,700Quality and Regulatory (AQR)
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About this role

A Senior Software Risk and Compliance Auditor at Abbott is a senior member of the Abbott Quality and Regulatory (AQR) corporate compliance audit function focused on medical device and related software. The role centers on assessing software compliance with global regulations and standards to support patient safety and regulatory alignment across Abbott’s manufacturing sites. It also supports integration of audit findings into divisional and executive-level risk awareness.

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Required Skills

  • IEC 62304
  • ISO 13485
  • ISO 14971
  • GAMP5 CSV
  • FDA 21 CFR
  • Auditing
  • Risk Management
  • Software Validation
  • QMS
  • Communication

+5 more

Qualifications

  • Bachelor's Degree
  • Lead Auditor Certificate
  • ISO Lead Auditor
Abbott Laboratories

About Abbott Laboratories

abbott.com

Innovative medical devices and health care solutions for cardiovascular health, diabetes management, diagnostic testing, nutrition, chronic pain and more.

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