Manufacturing Quality Engineer II – CAPA Lead

Edwards Lifesciences Gruppe; Redhill; On-site; GBP 42,000 - 62,000; Full time

Job summary

Edwards Lifesciences is seeking an Engineer II, Manufacturing Quality Assurance to support CAPA investigations and root cause analysis in a highly regulated environment. You will lead continuous improvement using Lean and Six Sigma, drive corrective actions, and collaborate with Manufacturing, Quality, and Engineering to strengthen product quality and regulatory compliance.

Onsite presence is required to provide direct support to manufacturing operations and participate in CAPA Review Board

Qualifications

• Bachelor's degree in Engineering or Science required.
• 2 years hands‑on experience solving manufacturing or quality challenges in a regulated environment.
• Onsite presence is required as this role provides direct support to manufacturing operations.
• Medical device industry experience preferred.
• Lean, Six Sigma, or other continuous improvement certification preferred.
• Experience with quality systems, CAPA requirements, root cause analysis methods, and verification of effectiveness.

Responsibilities

• Lead CAPA investigations related to manufacturing quality and compliance issues.
• 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 and operational excellence.
• 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.

Skills

CAPA investigations

Root cause analysis

Continuous improvement

Lean

Six Sigma

Risk management

Documentation

Cross-functional collaboration

Training materials

Process improvement

Knowledge transfer

MS Office

Education

Bachelor's degree in Engineering or Science

Tools

MS Project

MS Office Suite

Job description

Edwards Lifesciences is seeking an Engineer II, Manufacturing Quality Assurance to support CAPA investigations and root cause analysis in a highly regulated environment. You will lead continuous improvement using Lean and Six Sigma, drive corrective actions, and collaborate with Manufacturing, Quality, and Engineering to strengthen product quality and regulatory compliance.

Onsite presence is required to provide direct support to manufacturing operations and participate in CAPA Review Board