Quality Systems & CAPA Engineer II

Overview

Quality Engineer II supporting the Corrective and Preventive Action (CAPA) program within Irvine Implant Manufacturing, partnering with manufacturing operations and sales teams to improve product quality and patient outcomes.

What you'll do

• 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 overall 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 to support process consistency, operational excellence, and effective knowledge transfer.
• 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.

What you'll need

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

Nice to have

• Medical device industry experience.
• Lean, Six Sigma, or other continuous improvement certification.
• Experience with engineering methods (e.g., Six Sigma, LEAN methods, process flow charts, value stream mapping, statistics, and validation) for problem solving, continuous process improvement and sustaining manufacturing support.
• Understanding statistical and Six Sigma Techniques (Control Charting, DOE, Hypothesis Testing, Gage R&R, Z-Score, Tolerance Analysis, COV, 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 in usage of MS Office Suite including MS Project.

Details

• Location: Irvine, California, USA.
• Onsite presence is required as this role provides direct support to manufacturing operations.
• Base pay range for California: $87,000 to $123,000 (highly experienced); actual pay depends on qualifications, education and prior experience.