Senior Global Quality Compliance Auditor

Regulatory Jobs; Irvine (CA); On-site; USD 81,000 - 116,000; Full time

Job summary

Edwards Lifesciences seeks a Senior Analyst, Quality Compliance to strengthen the global Quality Management System through internal audits, CAPA processes, and continuous improvement. You will drive risk-based auditing, support regulatory readiness, and collaborate with cross-functional teams worldwide to ensure sustainable compliance and inspection readiness.

The role emphasizes partnering with stakeholders to manage audit findings and leverage quality metrics to identify trends and

Qualifications

• Bachelor's degree with ≥5 years in Quality Assurance, Quality Systems, Auditing, and/or Regulatory.
• Experience within a regulated industry.
• Willingness to work 100% onsite.
• Medical device industry experience is preferred.
• Experience with FDA QMSR, ISO 13485, and risk-based quality system principles.
• Lead Auditor certification or ASQ CQA, Six Sigma, Lean is a plus.

Responsibilities

• Conduct compliance assessments, gap analyses, and quality system audits to evaluate regulatory compliance across sites and functions.
• Manage audit findings, CAPAs, and monitor effectiveness for timely closure.
• Analyze audit results and quality metrics to identify trends and opportunities for improvement.
• Develop and implement risk-based auditing strategies to strengthen inspection readiness and regulatory readiness.
• Coordinate quality audits and regulatory inspections, including planning, execution, reporting, and follow-up.
• Lead inspection readiness activities and provide guidance on regulatory requirements to cross-functional teams.

Skills

Quality auditing

Regulatory compliance

Risk-based auditing

CAPA management

Regulatory inspections

Education

Bachelor's degree

Job description

Edwards Lifesciences seeks a Senior Analyst, Quality Compliance to strengthen the global Quality Management System through internal audits, CAPA processes, and continuous improvement. You will drive risk-based auditing, support regulatory readiness, and collaborate with cross-functional teams worldwide to ensure sustainable compliance and inspection readiness.

The role emphasizes partnering with stakeholders to manage audit findings and leverage quality metrics to identify trends and