Onsite Senior Quality Compliance Auditor

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 81,000 - 116,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA invites a Senior Analyst, Quality Compliance to strengthen the global Quality Management System through audits and continuous improvement.

You will partner with cross-functional teams to drive CAPAs, risk-based auditing, and regulatory readiness, including FDA QMSR and ISO 13485 compliance. This on-site role offers competitive compensation and benefits.

Qualifications

• Bachelor’s degree with minimum 5 years of experience in Quality Assurance, Quality Systems, Auditing, and/or Regulatory roles.
• Experience in a regulated industry and on-site work in California.

Responsibilities

• Conduct compliance assessments, gap analyses, and quality system audits across sites to evaluate compliance with global regulatory requirements, company procedures, and ISO 13485/GxP standards.
• Partner with quality and business stakeholders to manage audit findings, CAPAs, and monitor effectiveness for timely closure and sustainable improvements.
• Analyze audit results, CAPA data, and quality metrics to identify trends and opportunities to strengthen audit programs and the Quality Management System.
• Support risk-based auditing strategies to improve inspection readiness and regulatory oversight, including FDA QMSR expectations.
• Coordinate audits and regulatory inspections, including planning, schedule, preparation, execution, reporting, and follow-up.

Skills

Quality Assurance

Auditing

Regulatory Compliance

CAPA

Risk Management

Data Analytics

Quality Metrics

FDA Regulations

ISO 13485

GxP

Education

Bachelor’s degree

Tools

QMS Software

Job description

Edwards Lifesciences in Irvine, CA invites a Senior Analyst, Quality Compliance to strengthen the global Quality Management System through audits and continuous improvement.

You will partner with cross-functional teams to drive CAPAs, risk-based auditing, and regulatory readiness, including FDA QMSR and ISO 13485 compliance. This on-site role offers competitive compensation and benefits.