Edwards Lifesciences

Complaint Quality Engineer II - PMS

USA - California – Irvine · Mid · Internship

Sponsorship not specified$87k-$123kDetected 7 days ago

Data AnalysisPatient CareMedical DevicesLeadershipCommunication

About the role

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.
It's our driving force to help patients live longer and healthier lives.

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.
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.
Support external regulatory or competent authority requests with complaint risk and metric analysis as needed.
Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.

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 with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.

Complaints investigation experience and/or hands-on experience with device investigations
Demonstrated experience with risk management/risk assessments
Experience working in lab environment and familiarity with common measurement/test equipment (calipers, micrometers, pressure gages, leak testing, etc.)
Experience with data analysis and able to generate metrics for trending and review
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Ability to interact professionally with all organizational levels

For California, the base pay range for this position is $87,000 to $123,000 (highly experienced).

This listing is sourced directly from Edwards Lifesciences's careers page and normalized into a canonical job model.