Please note this is an "onsite" role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.

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 manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Perform assessment for similar incident reportable complaints to identify rate and possible escalation.
• 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 Project 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 or Master’s degree in Engineering or Scientific field.

What else we look for (Preferred Qualifications):

• Engineering degree
• Medical Device, Pharma, Biotech, or other Lifesciences industry experience
• Experience with product or device complaints, investigations, and/or root cause analysis
• Experience with NCRs, FMEAs, CAPAs, or Product Risk Assessments
• Familiar with key technologies and processes related to the assembly and manufacture of Class III cardiovascular devices and delivery systems

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 $67,000 to $96,000 (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.