Senior Manufacturing QA Engineer: Process Excellence & Impact

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

Job summary

Edwards Lifesciences is seeking a Senior Engineer, Manufacturing Quality Assurance to drive quality across the product lifecycle. You will investigate manufacturing quality issues, drive CAPA, and collaborate with design, manufacturing and R&D teams to raise standards and prevent defects.

You’ll develop risk management content, training materials, and documentation while coaching technicians and aligning projects with Six Sigma/LEAN principles in a fast-paced environment.

Qualifications

• Bachelor's degree in Engineering or related field with 4 years of experience.
• Master's degree or equivalent in Engineering or related field with 3 years related industry or industry/education experience.
• Ph.D. or equivalent in Engineering or related field with 0 years experience.
• Previous experience working 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

Problem solving

Analytical skills

Communication skills

Team collaboration

Education

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in Engineering

Tools

MS Office Suite

CAD

Job description

Edwards Lifesciences is seeking a Senior Engineer, Manufacturing Quality Assurance to drive quality across the product lifecycle. You will investigate manufacturing quality issues, drive CAPA, and collaborate with design, manufacturing and R&D teams to raise standards and prevent defects.

You’ll develop risk management content, training materials, and documentation while coaching technicians and aligning projects with Six Sigma/LEAN principles in a fast-paced environment.