Senior Analyst, Quality Compliance

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Analyst, Quality Compliance position is a unique career opportunity that could be your next step towards an exciting future.

The Senior Analyst, Quality Compliance will play a key role in strengthening Edwards' global Quality Management System through internal auditing, quality compliance, and continuous improvement activities. This position supports the planning and execution of external, corporate, and internal audits across quality systems and business functions, helps drive effective corrective and preventive action (CAPA) processes, and leverages audit data and quality metrics to identify risks and opportunities for improvement.

Working closely with cross-functional teams worldwide, you will help advance a risk-based approach to compliance, support regulatory readiness, and contribute to the ongoing evolution of Edwards' audit programs to meet global regulatory requirements.

• 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, including requirements supporting MDSAP countries.
• Partner with quality and business stakeholders to manage audit findings, facilitate corrective and preventive actions (CAPAs), and monitor effectiveness to ensure timely closure and sustainable compliance improvements.
• Analyze audit results, CAPA data, and quality metrics to identify trends, emerging risks, and opportunities to enhance the effectiveness of the audit programs and Quality Management System.
• Support the development and implementation of risk-based auditing strategies to strengthen compliance oversight, improve inspection readiness, and address evolving regulatory requirements, including FDA QMSR expectations.
• Support the administration, execution, and continuous improvement of quality audit and compliance programs, including internal, corporate, and external audits.
• 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, preparing stakeholders, and supporting interactions with regulatory agencies and notified bodies.
• Serve as a quality compliance subject matter expert, partnering with cross-functional teams to provide guidance on regulatory requirements, audit expectations, and quality system compliance.

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

• Medical device industry experience.
• Experience conducting, supporting, or participating in audits within a regulated industry.
• Experience supporting FDA inspections, Notified Body audits, or other regulatory inspections.
• Familiarity with FDA Quality Management System Regulation (QMSR), ISO 13485, and risk-based quality system principles.
• Experience working in a manufacturing or operations environment.
• Experience with regulatory compliance activities.
• Experience working with CAPAs, investigations, and continuous improvement initiatives across quality systems.
• Knowledge of MDSAP…