Onsite Supplier Quality Engineer II - Travel & Impact

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

Job summary

Edwards Lifesciences seeks a Supplier Quality Engineer II in California to lead supplier qualification activities, support product development, and ensure regulatory and quality-system compliance in a fast-paced environment.

You will perform gage studies, develop test methods with SolidWorks, conduct on-site supplier audits, manage non-conformances and CAPAs, and collaborate across R&D, Manufacturing, and Regulatory affairs to deliver robust medical devices.

Qualifications

• Bachelor’s degree in engineering or scientific field required.
• Experience in supplier quality, quality, manufacturing, or production engineering is preferred.
• Willingness to travel up to 15%–20% and work onsite 100%.
• Knowledge of GD&T and reading drawings is beneficial.

Responsibilities

• Lead supplier qualification activities from initiation to closure.
• Perform on-site supplier audits and manage supplier-related non-conformances.
• Support CAPA investigations and effectiveness across the supply base.
• Develop test methods and inspection routines, including fixtures and methods in SolidWorks.
• Provide engineering support to Receiving Inspection and document risk mitigations.

Skills

Gage R&R

Statistical Process Control

Process Capability Studies

Root Cause Analysis

CAPA investigations

Education

Bachelor's degree in engineering or scientific field

Master's degree (engineering or science)

Tools

SolidWorks

Job description

Edwards Lifesciences seeks a Supplier Quality Engineer II in California to lead supplier qualification activities, support product development, and ensure regulatory and quality-system compliance in a fast-paced environment.

You will perform gage studies, develop test methods with SolidWorks, conduct on-site supplier audits, manage non-conformances and CAPAs, and collaborate across R&D, Manufacturing, and Regulatory affairs to deliver robust medical devices.