Quality Engineer, Complaints & Investigations

Edwards; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards in Irvine, CA, is seeking a Quality Engineer to support complaint investigations, product failure analysis, and documentation review within our transcatheter heart valve business.

You will investigate complex manufacturing quality issues, perform root cause analyses, and prepare technical investigation reports while aligning with risk management and regulatory expectations. Collaboration with engineering and manufacturing teams is essential.

Qualifications

• Bachelor’s or Master’s in engineering/science with relevant QA experience.
• Experience with root cause analysis or investigations for complaints, NCRs, and/or CAPAs.
• Ability to work in a medical device regulated environment preferred.

Responsibilities

• Investigate complex quality issues and determine root cause.
• Support regulatory requests with risk analysis.
• Assess events against risk documentation and escalate as needed.
• Participate in CAPAs and product risk assessments.
• Identify and report complaint metrics with cross-functional teams.
• Assist in ad-hoc complaint analysis or metric reviews.

Skills

Root cause analysis

Investigations

Data analysis

Statistical methods

Quality systems

Education

Bachelor's degree in engineering/science

Master's degree in engineering/science

Tools

Calipers

Micrometers

Pressure gauges

Leak testing

Job description

Edwards in Irvine, CA, is seeking a Quality Engineer to support complaint investigations, product failure analysis, and documentation review within our transcatheter heart valve business.

You will investigate complex manufacturing quality issues, perform root cause analyses, and prepare technical investigation reports while aligning with risk management and regulatory expectations. Collaboration with engineering and manufacturing teams is essential.