Complaint Quality Engineer II - PMS

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

This Quality Engineer will support, perform, and/or complete assigned complaint investigations that include (but are not limited to) product failure analysis and complaint documentation review (device history record, complaint history, products instructions, risk management, etc.), and prepare technical investigation reports.

How you will make an impact:

- Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.

- Support external regulatory or competent authority requests with complaint risk and metric analysis as needed.

- Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.

- Participate in escalation tasks and activities, including Product Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determination by investigation.

- Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.

- Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).

What you'll need (Required Qualifications):

- Bachelor's Degree in Engineering/Scientific field with 2 years of experience in Quality Engineering or Quality Assurance; OR Master’s degree in Engineering or Scientific field with either no experience (or internship experience).

- Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.