Supplier Quality Engineer II — Medical Device NPD

Edwards; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences is seeking a Supplier Quality Engineer II for component new product development in California. You will lead supplier qualification activities, resolve quality issues, and partner with R&D, Design Assurance, and Operations to ensure product quality across development and launch timelines.

The role requires a 2+ year background in supplier quality or related fields, strong regulatory acumen, and ability to travel up to 20%. Onsite work in a fast-paced environment is expected.

Qualifications

• Bachelor’s degree in engineering or science with 2+ years in supplier quality, manufacturing or production engineering.
• Highly regulated industry experience.
• Willingness to travel up to 15–20% and work onsite 100%.
• Preferred: Medical Device, Aerospace, or Automotive experience; Design Controls knowledge.

Responsibilities

• Lead supplier qualification activities from initiation to closure.
• Support CAPA/non-conformances and problem-solving.
• Validate and improve processes and risk documentation; drive Lean/Six Sigma improvements.
• Report supplier qualification status at cross-functional project meetings.

Skills

Root cause analysis

CAPA investigations

Quality systems

Regulatory knowledge

Travel willingness

Education

Bachelor's degree in engineering or scientific field

Master’s degree (with no experience)

Tools

Gage R&R

SPC

Process Capability Studies

GD&T

SolidWorks

IQ/OQ/PQ

Job description

Edwards Lifesciences is seeking a Supplier Quality Engineer II for component new product development in California. You will lead supplier qualification activities, resolve quality issues, and partner with R&D, Design Assurance, and Operations to ensure product quality across development and launch timelines.

The role requires a 2+ year background in supplier quality or related fields, strong regulatory acumen, and ability to travel up to 20%. Onsite work in a fast-paced environment is expected.