CAPA & Quality Systems Engineer II - Impact Patients

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

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.