Senior Quality Compliance Analyst — Onsite Audits

Edwards Lifesciences Gruppe; East Alton (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

Edwards Lifesciences seeks a Senior Analyst, Quality Compliance to strengthen its global Quality Management System through internal auditing, CAPA, and continuous improvement activities.

The role supports planning and execution of external, corporate, and internal audits, analyzes CAPA data to identify risks, and collaborates with cross-functional teams to enhance risk-based auditing and regulatory readiness. Onsite collaboration across sites is required.

Qualifications

• Bachelor’s degree with minimum 5 years of experience in Quality Assurance, Quality Systems, Auditing, and/or Regulatory, or equivalent work experience based on Edwards’ criteria.
• Experience within a regulated industry.
• Ability and willingness to work 100% onsite.

Responsibilities

• Conduct compliance assessments, gap analyses, and quality system audits across sites and functions.
• 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, emerging risks, and opportunities.
• Support the development and implementation of risk-based auditing strategies to strengthen compliance oversight and inspection readiness.
• Support the administration, execution, and continuous improvement of quality audit and compliance programs.
• Coordinate and support quality audits and regulatory inspections including planning, scheduling, preparation, execution, reporting, and follow-up activities.
• Lead inspection readiness activities by assessing compliance risks and interacting with regulatory agencies.

Skills

Quality Assurance

Regulated industry experience

Onsite work

Education

Bachelor’s degree

Job description

Edwards Lifesciences seeks a Senior Analyst, Quality Compliance to strengthen its global Quality Management System through internal auditing, CAPA, and continuous improvement activities.

The role supports planning and execution of external, corporate, and internal audits, analyzes CAPA data to identify risks, and collaborates with cross-functional teams to enhance risk-based auditing and regulatory readiness. Onsite collaboration across sites is required.