Senior Manufacturing QA Engineer — Global Impact & Compliance

Regulatory Jobs; 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 product quality and regulatory compliance across the full lifecycle of our medical devices. You will apply quality engineering principles to optimize product development, manufacturing, and distribution while collaborating with cross-functional teams.

The role emphasizes problem solving, process improvement with Six Sigma/LEAN, documentation, coaching junior staff, and creating

Qualifications

• Bachelor’s Degree in Engineering required.
• Master’s Degree or Ph.D. in Engineering or related field.
• Experience with lab/industrial equipment.

Responsibilities

• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop, update, and maintain technical content of risk management files.
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Train, coach, and guide junior employees on routine procedures.

Skills

Six Sigma

Lean

Problem Solving

Documentation

Communication

Education

Bachelor’s Degree in Engineering

Master’s Degree in Engineering

Ph.D. in Engineering

Tools

MS Office Suite

CAD

Job description

Edwards Lifesciences in Irvine, CA is seeking a Senior Engineer, Manufacturing Quality Assurance to help ensure product quality and regulatory compliance across the full lifecycle of our medical devices. You will apply quality engineering principles to optimize product development, manufacturing, and distribution while collaborating with cross-functional teams.

The role emphasizes problem solving, process improvement with Six Sigma/LEAN, documentation, coaching junior staff, and creating