Quality Systems & CAPA Engineer II

Edwards Lifesciences Gruppe; Redhill (MD); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences is seeking a Quality Engineer II to support CAPA investigations within Irvine Implant Manufacturing. You will lead root cause analyses, develop corrective actions, and monitor CAPA progress in a highly regulated medical device environment.

The role requires a Bachelor's degree in Engineering or Science with hands-on experience, on-site presence, and familiarity with FDA QSR, ISO 13485, and lean methodologies to sustain product quality and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering or Science with 2 years' manufacturing/quality experience.
• Onsite presence required to support manufacturing operations.

Responsibilities

• Lead CAPA investigations related to manufacturing quality and compliance.
• Perform root cause analysis and drive corrective actions.
• Support CAPA progress tracking and effectiveness verification.
• Collaborate with Manufacturing, Quality, and Engineering teams.
• Provide guidance to CAPA owners and cross-functional teams.
• Prepare CAPA Board materials and document decisions.

Skills

CAPA investigations

Root cause analysis

Manufacturing quality

Continuous improvement

Risk management

FDA Quality System

MS Office

MS Project

Education

Bachelor's degree in Engineering or Science

Tools

MS Office Suite

MS Project

Job description

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 a 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.

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).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.