Quality Compliance Lead, Global Audits & CAPA

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

Job summary

Edwards Lifesciences is seeking a Senior Analyst, Quality Compliance to strengthen the global Quality Management System through audits, CAPA, and continuous improvement. You will coordinate internal, external, and regulatory audits, drive risk-based strategies, and support FDA QMSR and ISO 13485 compliance across sites worldwide.

The role requires 5+ years in quality assurance and regulatory environments, with onsite work mandatory.

Qualifications

• Bachelor’s degree with minimum 5 years of experience in Quality Assurance, Quality Systems, Auditing, and/or Regulatory, or equivalent work experience.
• Experience within a regulated industry.
• Ability and willingness to work 100% onsite.
• Lead Auditor certification, ASQ CQA, Six Sigma, Lean, or related certification (preferred).
• Experience with regulatory inspections and CAPA processes.

Responsibilities

• Conduct compliance assessments, gap analyses, and quality system audits across sites and functions to evaluate compliance with global regulatory requirements, company procedures, and applicable quality standards.
• Partner with quality and business stakeholders to manage audit findings, CAPAs, and monitor effectiveness.
• Analyze audit results, CAPA data, and quality metrics to identify trends and opportunities for improvement.
• Support development of risk-based auditing strategies to strengthen compliance oversight and inspection readiness.
• Coordinate and support audits and regulatory inspections including planning, execution, and follow-up.
• Lead inspection readiness activities and interact with regulatory agencies and notified bodies.
• Serve as a quality compliance SME, guiding teams on regulatory requirements and audit expectations.

Skills

Quality Assurance

Auditing

Regulatory compliance

Risk management

Quality systems

Education

Bachelor's degree in related field

Job description

Edwards Lifesciences is seeking a Senior Analyst, Quality Compliance to strengthen the global Quality Management System through audits, CAPA, and continuous improvement. You will coordinate internal, external, and regulatory audits, drive risk-based strategies, and support FDA QMSR and ISO 13485 compliance across sites worldwide.

The role requires 5+ years in quality assurance and regulatory environments, with onsite work mandatory.