Complaint Investigation Quality Engineer II

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

Job summary

Edwards Lifesciences in California Irvine is seeking a Quality Engineer to support complaint investigations, root cause analysis, and documentation review across device history records and risk management.

You will analyze field issues, prepare investigation reports, support regulatory requests, and contribute to CAPAs and risk assessments. A Bachelor's in Engineering or Science with 2 years QA experience (or Master's with internship) is required. Vaccination against COVID-19 is required.

Qualifications

• Experience in root cause analysis or investigations for Complaints, NCRs, and CAPAs.
• Experience with medical devices in regulated environments is preferred.
• Strong documentation and communication skills.

Responsibilities

• 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 accelerate 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).

Skills

Root cause analysis

Investigations

Data analysis

Communication

Education

Bachelor's Degree in Engineering/Scientific field

Master’s degree in Engineering/Scientific field

Tools

Calipers

Micrometers

Pressure gauges

Leak testing

Job description

Edwards Lifesciences in California Irvine is seeking a Quality Engineer to support complaint investigations, root cause analysis, and documentation review across device history records and risk management.

You will analyze field issues, prepare investigation reports, support regulatory requests, and contribute to CAPAs and risk assessments. A Bachelor's in Engineering or Science with 2 years QA experience (or Master's with internship) is required. Vaccination against COVID-19 is required.