Manufacturing QA Engineer II — CAPA & Process Improvement

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

Job summary

Edwards Lifesciences in Irvine, CA is seeking an Engineer II, Manufacturing Quality Assurance to lead CAPA investigations, root cause analysis, and corrective actions that strengthen quality, compliance, and manufacturing performance.

In this onsite role, you will partner with Manufacturing, Quality and Engineering to drive Lean Six Sigma initiatives, risk management documentation, and process improvements across the product lifecycle to protect patient outcomes.

Qualifications

• Bachelor's degree in Engineering or Scientific field required.
• 2+ years of hands-on experience solving manufacturing or quality challenges in a highly regulated environment recommended.
• Experience leading investigations, CAPAs, and driving process improvements.

Responsibilities

• Lead investigations into manufacturing quality and compliance issues, including CAPAs, nonconformances, and audit observations.
• Perform root cause analysis, develop effective solutions, and drive actions that improve product quality, patient safety, and regulatory compliance.
• Drive continuous improvement initiatives across manufacturing operations using Lean and Six Sigma methodologies.
• Partner with cross-functional teams to assess and mitigate product and process risks by developing, updating, and maintaining risk management documentation.
• Create and improve manufacturing documentation, work instructions, and training materials.
• Provide technical guidance and mentorship to technicians, coordinate testing, and support engineering projects.

Skills

Root cause analysis

Investigations

Continuous improvement

Cross-functional collaboration

Lean Six Sigma

Education

Bachelor's degree in Engineering or Scientific field

Tools

MS Office

MS Project

Job description

Edwards Lifesciences in Irvine, CA is seeking an Engineer II, Manufacturing Quality Assurance to lead CAPA investigations, root cause analysis, and corrective actions that strengthen quality, compliance, and manufacturing performance.

In this onsite role, you will partner with Manufacturing, Quality and Engineering to drive Lean Six Sigma initiatives, risk management documentation, and process improvements across the product lifecycle to protect patient outcomes.