Senior Analyst, Quality Compliance

Edwards Lifesciences Gruppe; Irvine (CA); Vor Ort; USD 81.000 - 116.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Assurance

Auditing

Regulatory Compliance

CAPA

Risk Management

Data Analytics

Quality Metrics

FDA Regulations

ISO 13485

GxP

Ausbildung

Bachelor’s degree

Tools

QMS Software

Jobbeschreibung

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 environmentMust 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.