Senior Compliance Auditor I

Abbott

Abbott Park, Illinois, United States
Base: $99,300.00 – $198,700.00; bonus/equity: not ...
Hybrid (as the role works out of the abbott park location and other applicable sites, but specific remote work details were not specified)
Medical device auditing experience
Iso 13485 and fda qmsr knowledge
Risk-based audit program development
Abbott is seeking a Senior Compliance Auditor I to oversee compliance audits for its Quality and Regulatory Global compliance audit function, focusing on medical devices and in vitro diagnostics. The ideal candidate will have extensive experience in auditing within the medical device industry and a strong understanding of applicable regulations and quality management systems

Job Summary

  • This role ensures executive management is aware of compliance business risks and regulatory requirements across Abbott's global manufacturing sites.
  • The position involves conducting in-depth risk-based Quality System audits focusing on patient safety and adherence to standards like ISO 13485 and FDA 21 CFR Part 820.
  • Employees qualify for benefits including free medical coverage, a high employer contribution retirement plan, and tuition reimbursement programs.

Matching Summary

Match Score: 85

Abbott is seeking a Senior Compliance Auditor I to oversee compliance audits for its Quality and Regulatory Global compliance audit function, focusing on medical devices and in vitro diagnostics. The ideal candidate will have extensive experience in auditing within the medical device industry and a strong understanding of applicable regulations and quality management systems.

Salary

Base: $99,300.00 – $198,700.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Medical device auditing experience
  • ISO 13485 and FDA QMSR knowledge
  • Risk-based audit program development
  • Design control and validation expertise
  • Global regulatory requirements understanding

Nice-to-have

  • Lead auditor certificate preferred
  • Strong cross-divisional communication skills
  • Experience with MDSAP or country specific regulations
  • Ability to work independently without supervision

Key Requirements

  • Four-year degree in scientific, technical, or compliance discipline
  • 7+ years of experience in the medical device industry
  • Proven history working on risk-based design controls
  • Lead auditor certificate for Quality System audits desirable

Work Rights

Not specified

Tailored Resume

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