ED
EdwardsSenior Analyst, Quality Compliance
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Before you apply
Salary$81k – $116k
LocationUSA - California – Irvine
Work modeon-site
Typefull-time
SenioritySenior
Experience5+ yrs
DepartmentQuality Compliance
Company size10,000+ people
PostedOct 7, 2026 · 1mo ago
Verified live3d ago
At a glanceSummarised by Seekless from the posting.
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
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
Ability and willingness to work 100% onsite
Skills
ISO 13485
21 CFR 820
EU MDR
MDSAP
Benefits
Performance based incentives
About the company
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.
About the role
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.
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Support the administration, execution, and continuous improvement of quality audit and compliance programs, including internal, corporate, and external audits.
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Coordinate and support quality audits and regulatory inspections including planning, scheduling, preparation, execution, reporting, and follow-up activities.
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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.
Benefits
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.
Legal
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.