Quality Engineer II, Complaints & Risk Analytics

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

Job summary

Edwards Lifesciences Gruppe in Irvine, CA seeks a Quality Engineer to support, perform, and complete complaint investigations, including root cause analysis and documentation review (device history record, complaint history, risk management, etc.).

You will investigate complex manufacturing quality issues, support CAPAs/SCARs, and contribute to risk assessments and metric reporting, working with cross-functional teams.

Qualifications

• Bachelor's degree in Engineering or Scientific field required; 2+ years in Quality Engineering or related role.
• Experience with root cause analysis or investigations for Complaints, NCRs, and CAPAs preferred.
• Experience in medical devices regulatory environment and risk management is desirable.
• Strong documentation, communication, and data analysis skills.

Responsibilities

• Investigate complex manufacturing quality and compliance issues reported from the field.
• Analyze results to determine root/probable cause and initiate/review reports.
• Support regulatory or competent authority requests with risk assessment and metrics as needed.
• Participate in risk assessments (PRA) and CAPAs, SCARs per investigation outcomes.
• Identify and report key complaint metrics and collaborate with manufacturing teams to resolve issues.

Skills

Root cause analysis

Data analysis

Risk assessments

Quality systems

Investigation experience

Education

Bachelor's degree in Engineering or Scientific field

Master’s degree in Engineering or Scientific field

Tools

Calipers

Micrometers

Pressure gauges

Leak testing equipment

Job description

Edwards Lifesciences Gruppe in Irvine, CA seeks a Quality Engineer to support, perform, and complete complaint investigations, including root cause analysis and documentation review (device history record, complaint history, risk management, etc.).

You will investigate complex manufacturing quality issues, support CAPAs/SCARs, and contribute to risk assessments and metric reporting, working with cross-functional teams.