Sr. Manager, Quality Engineering

Abbott

Abbott Park, IL, United States
Base: $129,300.00 – $258,700.00; bonus/equity: not...
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Quality management system (qms) compliance
Fda qmsr (21 cfr 820) and iso 13485 standards
Data-driven quality strategies
** Abbott is seeking a Senior Manager of Quality Engineering to lead and oversee quality management systems and compliance across its operations, ensuring regulatory adherence while driving business performance. The role requires extensive experience in regulated industries, particularly in medical devices and quality assurance. **

Job Summary

  • The Senior Manager, Quality Engineering provides enterprise-level leadership across Quality Engineering and Compliance functions, ensuring the effectiveness, sustainability, and business integration of the Quality Management System.
  • This role serves as a key quality leader influencing decisions across manufacturing, engineering, supply chain, and capital delivery functions, while advising executive leadership on quality performance, trends, and risk.
  • Abbott is a global healthcare leader with a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.

Matching Summary

Match Score: 75

** Abbott is seeking a Senior Manager of Quality Engineering to lead and oversee quality management systems and compliance across its operations, ensuring regulatory adherence while driving business performance. The role requires extensive experience in regulated industries, particularly in medical devices and quality assurance. **

Salary

Base: $129,300.00 – $258,700.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Quality Management System (QMS) compliance
  • FDA QMSR (21 CFR 820) and ISO 13485 standards
  • Data-driven quality strategies
  • Regulatory inspections and external audits
  • Cross-functional quality leadership
  • Operational risk reduction
  • Quality metrics and performance monitoring

Nice-to-have

  • Change leadership capability
  • Financial and commercial acumen
  • Culture of continuous improvement
  • Talent development and coaching
  • Global and matrixed organization experience
  • Standardization and automation of reporting

Key Requirements

  • Bachelor’s degree in engineering, Science, Quality, or Regulatory Affairs
  • Master’s degree preferred
  • 10+ years progressive experience in regulated industries
  • Strong understanding of FDA QMSR and ISO 13485
  • Experience leading Quality organizations with enterprise influence
  • Travel requirement of approximately 10%

Work Rights

Not specified

Tailored Resume

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