Complaints Quality Engineer II – Medical Devices

Edwards Lifesciences Gruppe; United States; On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences is seeking a Quality Engineer to support, perform, and complete complaint investigations, including root cause analysis, CAPAs, and risk assessments.

The role involves reviewing device history records, complaint histories, risk management, and regulatory responses, with emphasis on data-driven metrics and cross-functional collaboration. California base pay indicates a strong, regulated environment.

Qualifications

• Bachelor's or Master's in engineering/science with related experience in Quality Engineering or QA.
• Experience with root cause analysis or investigations for Complaints, NCRs, and CAPAs.

Responsibilities

• Investigate complex manufacturing 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 elevate to Quality Management and Product Safety as needed.
• Participate in escalation tasks and activities, including Product Risk Assessments (PRA) and Corrective/Preventive actions - 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

Quality assurance

Documentation

Data analysis

Medical devices

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 is seeking a Quality Engineer to support, perform, and complete complaint investigations, including root cause analysis, CAPAs, and risk assessments.

The role involves reviewing device history records, complaint histories, risk management, and regulatory responses, with emphasis on data-driven metrics and cross-functional collaboration. California base pay indicates a strong, regulated environment.