Senior Analyst, Quality Compliance

Edwards Lifesciences•Irvine, CA

7d•Onsite

About The Position

Edwards Lifesciences is seeking a Senior Analyst, Quality Compliance to strengthen its global Quality Management System. This role involves internal auditing, quality compliance, and continuous improvement. The position supports the planning and execution of external, corporate, and internal audits across quality systems and business functions. It also helps drive effective corrective and preventive action (CAPA) processes and uses audit data and quality metrics to identify risks and opportunities for improvement. The Senior Analyst will work closely with cross-functional teams worldwide to advance a risk-based approach to compliance, support regulatory readiness, and contribute to the evolution of Edwards' audit programs to meet global regulatory requirements.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.