Senior Manufacturing QA Engineer: Impact Medical Devices

Edwards; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Engineer, Manufacturing Quality Assurance to help ensure the highest standards of quality across product development and manufacturing.

You will apply quality engineering principles to regulatory compliance, develop training materials, lead CAPA investigations, and support continuous improvement of manufacturing and R&D processes to deliver safe, innovative heart-related devices worldwide.

Qualifications

• Bachelor's or higher in Engineering or related field with 4 years of related industry experience; or
• Master's degree with 3 years of related experience; or
• PhD with 0 years experience in Engineering or related field.

Responsibilities

• Investigate complex manufacturing quality and compliance issues (CAPA, non-conformances, audit observations) for all production processes and provide analyses and reports.
• Identify opportunities to optimize Manufacturing/R&D processes using Six Sigma and Lean methods to improve design for manufacturing and reduce risk.
• Develop, update, and maintain risk management files and documentation.
• Create training and production work instructions to enable knowledge transfer across projects and processes.
• Assign tasks, guide technicians, and provide training and feedback to ensure proper execution.
• Coach junior staff on routine procedures and best practices.

Skills

MS Office Suite

CAD

Documentation

Statistics

Education

Bachelor's Degree in Engineering or related field

Master's Degree or equivalent in Engineering or related field

Ph.D. or equivalent in Engineering or related field

Job description

Edwards Lifesciences in Irvine, CA is seeking a Senior Engineer, Manufacturing Quality Assurance to help ensure the highest standards of quality across product development and manufacturing.

You will apply quality engineering principles to regulatory compliance, develop training materials, lead CAPA investigations, and support continuous improvement of manufacturing and R&D processes to deliver safe, innovative heart-related devices worldwide.