Quality Systems & CAPA Engineer II

Edwards Lifesciences • Irvine, CA

1d • $87,000 - $123,000 • Onsite

About The Position

The Quality Systems & CAPA Engineer II primarily supports the Corrective and Preventive Action (CAPA) program within Irvine Implant Manufacturing. The role supports CAPA investigations, facilitates root cause analysis, partners with CAPA owners to develop appropriate corrective actions, monitors CAPA progress, and helps ensure actions are completed effectively and on time. It contributes directly to product quality, patient outcomes, patient safety, and regulatory compliance through collaboration with manufacturing operations and cross-functional teams.

Requirements

• Bachelor's degree in Engineering or a scientific field.
• At least 2 years of hands-on experience solving manufacturing or quality challenges, leading investigations, and driving process improvements in a highly regulated environment.
• Onsite presence is required to provide direct support to manufacturing operations.

Nice To Haves

• Medical device industry experience.
• Lean, Six Sigma, or other continuous improvement certification.
• Experience with engineering methods such as Six Sigma, Lean methods, process flow charts, value stream mapping, statistics, and validation for problem solving, continuous process improvement, and sustaining manufacturing support.
• Understanding of statistical and Six Sigma techniques, including Control Charting, DOE, Hypothesis Testing, Gage R&R, Z-Score, Tolerance Analysis, COV, and Regression.
• Knowledge of quality management systems, CAPA requirements, root cause analysis methodologies, corrective action planning, and verification of effectiveness.
• Experience conducting or reviewing investigations, evaluating objective evidence, and determining whether identified root causes and corrective actions are adequately supported.
• Working knowledge of applicable medical device quality system requirements, including FDA Quality System requirements, ISO 13485, EU MDR, and/or MDSAP.
• Good computer skills, including use of the MS Office Suite and MS Project.

Responsibilities

• Lead CAPA investigations related to manufacturing quality and compliance issues, including 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 the CAPA process and manufacturing operations using Lean and Six Sigma methodologies.
• Identify opportunities to optimize processes, reduce risk, improve efficiency, and enhance manufacturing performance.
• Partner with cross-functional teams to assess and mitigate product and process risks by developing, updating, and maintaining risk management documentation throughout the product lifecycle.
• Create and improve CAPA and quality system documentation, work instructions, and training materials.
• Provide technical guidance and support to CAPA owners and cross-functional teams through investigation, root cause analysis, corrective action development, and coaching.
• Collaborate with Manufacturing, Quality, and Engineering teams to implement sustainable solutions that strengthen product quality and regulatory compliance.
• Support and occasionally lead CAPA Review Board meetings, including preparing status updates, facilitating discussion, documenting decisions, and following up on action items.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level