Quality Systems & CAPA Engineer II

About the role

Imagine how your ideas and expertise can change a patient's life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You'll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry.

Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

Make a direct impact on product quality and patient outcomes as an Quality Engineer II primarily supporting the Corrective and Preventive Action (CAPA) program within Irvine Implant Manufacturing. In this role, you will support CAPA investigations, facilitate root cause analysis, partner with CAPA owners to develop appropriate corrective actions, monitor CAPA progress, and help ensure actions are completed effectively and on time.

How you will make an impact: 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 (Required): Bachelor's degree in Engineering or Scientific, with 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 as this role provides direct support to manufacturing operations. What else we look for (Preferred Qualifications): 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, is preferred. Good computer skills in usage of MS Office Suite including MS Project.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $87,000 to $123,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.