Manufacturing QA Engineer II - CAPA & Process Improvement

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

Job summary

Edwards Lifesciences is seeking an Engineer II, Manufacturing Quality Assurance to lead investigations, drive CAPAs, and improve process quality in a highly regulated environment. The role focuses on root cause analysis, corrective actions, and risk management within the CAPA framework. Onsite support to manufacturing operations is required, with emphasis on product quality and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering or Science required.
• 2 years of hands-on experience solving manufacturing or quality challenges.
• Onsite presence required in manufacturing operations.

Responsibilities

• Lead investigations into manufacturing quality and compliance issues (CAPAs, nonconformances, audits).
• Perform root cause analysis and drive corrective actions to improve product quality and safety.
• Drive continuous improvement across manufacturing using Lean Six Sigma methodologies.
• Develop, update, and maintain risk management documentation throughout the product lifecycle.
• Mentor technicians and coordinate testing activities to support engineering projects.

Skills

CAPA investigations

Root cause analysis

Lean Six Sigma

Quality assurance

Education

Bachelor's degree in Engineering or Science

Tools

MS Office

MS Project

Job description

Edwards Lifesciences is seeking an Engineer II, Manufacturing Quality Assurance to lead investigations, drive CAPAs, and improve process quality in a highly regulated environment. The role focuses on root cause analysis, corrective actions, and risk management within the CAPA framework. Onsite support to manufacturing operations is required, with emphasis on product quality and regulatory compliance.