Engineer II, Manufacturing Quality - CAPA & Improvement

Edwards Ltd; Redhill; On-site; GBP 66,000 - 93,000; Full time

Job summary

Edwards Lifesciences in Irvine, California, is seeking an Engineer II, Manufacturing Quality Assurance to support CAPA investigations and root-cause analysis, ensuring product quality and patient safety.

You will partner with Manufacturing, Quality and Engineering teams to implement corrective actions, drive CAPA progress, and promote continuous improvement through Lean and Six Sigma within a highly regulated environment.

Qualifications

• Bachelor's degree in Engineering or Science with 2 years' hands-on experience solving manufacturing or quality challenges in a highly regulated environment.
• Onsite presence is required to support manufacturing operations.
• Experience in the medical device industry and regulatory requirements is preferred.

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 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 maintaining risk 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 and action implementation.
• Collaborate with Manufacturing, Quality, and Engineering teams to implement sustainable solutions that strengthen product quality and regulatory compliance.
• Support CAPA Review Board meetings, including status updates, discussions, and tracking action items.

Skills

CAPA investigations

Root cause analysis

Lean Six Sigma

Quality management systems

Statistical methods

MS Office (MS Project)

Education

Bachelor's degree in Engineering or Science

Tools

MS Project

MS Excel

Document control systems

Job description

Edwards Lifesciences in Irvine, California, is seeking an Engineer II, Manufacturing Quality Assurance to support CAPA investigations and root-cause analysis, ensuring product quality and patient safety.

You will partner with Manufacturing, Quality and Engineering teams to implement corrective actions, drive CAPA progress, and promote continuous improvement through Lean and Six Sigma within a highly regulated environment.