Senior Compliance Auditor I

Abbott

Abbott Park, Illinois, United States
Base: $99,300.00 – $198,700.00; bonus/equity: not ...
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Iso 13485 regulatory compliance
Fda 21 cfr part 820 auditing
Risk-based quality system audits
** Abbott is seeking a Senior Compliance Auditor to lead risk-based audits in compliance with global standards in the medical device sector. The ideal candidate will have extensive experience in auditing, particularly in medical devices and in vitro diagnostics, with a strong emphasis on regulatory compliance and quality management systems. **

Job Summary

  • This role leads in-depth risk-based Quality System audits across Abbott manufacturing sites to ensure patient safety and regulatory compliance.
  • The position requires up to 50% domestic and international travel to conduct assessments and integrate information from compliance audits.
  • Employees qualify for free medical coverage, a high employer contribution retirement plan, and tuition reimbursement benefits.

Matching Summary

Match Score: 75

** Abbott is seeking a Senior Compliance Auditor to lead risk-based audits in compliance with global standards in the medical device sector. The ideal candidate will have extensive experience in auditing, particularly in medical devices and in vitro diagnostics, with a strong emphasis on regulatory compliance 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

  • ISO 13485 regulatory compliance
  • FDA 21 CFR Part 820 auditing
  • Risk-based quality system audits
  • Medical device design controls
  • EU MDR/IVDR regulation knowledge

Nice-to-have

  • Lead auditor certificate for Quality Systems
  • MDSAP and country specific requirements
  • Cross-divisional integration experience
  • Strong analytical problem-solving skills
  • Professional education development skills

Key Requirements

  • Four-year degree in scientific or technical discipline
  • 7+ years in the medical device industry
  • Proven history working on risk-based design
  • Lead auditor certificate desirable

Work Rights

Not specified

Tailored Resume

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