Senior Quality Engineer, MedTech Manufacturing

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

Benefits offered by this job

Competitive salary

Incentives

Benefits programs

Job summary

Edwards Lifesciences in Irvine, CA, is seeking a Manufacturing Sustaining Senior Quality Engineer to drive product quality across valve operations. You will investigate CAPA, non-conformances, and audit findings, applying Six Sigma and Lean methods to improve design for manufacturing and processes. Travel up to 5% may be required.

The role emphasizes training, documentation, risk management, and mentoring, with a strong focus on collaboration across departments and senior leadership interactions.

Qualifications

• Substantial understanding of Quality Engineering principles and concepts.
• Experience with quality systems and documentation practices.
• Strong statistical knowledge and problem-solving skills.
• Proven leadership and ability to influence change.
• Experience with laboratory or industrial equipment is a plus.

Responsibilities

• Support 1st shift of Irvine Implant Manufacturing's valve operations with RESILIA processing, sterilization and packaging.
• Investigate CAPA, non-conformances, audit findings and related quality issues across production.
• Apply Six Sigma and Lean methods to drive DFx and continuous improvement.
• Identify opportunities to design or redesign equipment and fixtures to reduce risk.
• Develop and maintain risk management files and work instructions.
• Coach technicians, assign tasks and ensure effective knowledge transfer.
• Guide junior staff and ensure adherence to procedures.

Skills

Quality Engineering

Six Sigma

Lean

Documentation

Negotiation

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Tools

MS Office Suite

Job description

Edwards Lifesciences in Irvine, CA, is seeking a Manufacturing Sustaining Senior Quality Engineer to drive product quality across valve operations. You will investigate CAPA, non-conformances, and audit findings, applying Six Sigma and Lean methods to improve design for manufacturing and processes. Travel up to 5% may be required.

The role emphasizes training, documentation, risk management, and mentoring, with a strong focus on collaboration across departments and senior leadership interactions.