Senior Analyst, Quality Compliance

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

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.

How you will make an impact:

• 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.

What you will need (Required):

• 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 within a regulated industry.
• Ability and willingness to work 100% onsite.

What else we look for (Preferred):

• 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 requirements and global medical device regulations.
• Proficient understanding of regulations and standards, including, but not limited to 21 CFR 820, ISO 13485:2016, EU MDR.
• Strong understanding of risk management principles and risk-based auditing.
• Experience developing and leveraging quality metrics, dashboards, data analytics, and visualization tools to identify trends and drive quality improvements.
• Lead Auditor certification, ASQ Certified Quality Auditor (CQA), Six Sigma, Lean, or related professional certification.
• Excellent written and verbal communication skills including negotiating and relationship management skills.
• Strong problem-solving and critical thinking skills.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment often requiring coordination within and between organizations.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $81,000 to $116,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.