Supplier Quality Engineer II — Onsite, High-Impact Role

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

Job summary

Edwards Lifesciences in Irvine, CA, seeks a Supplier Quality Engineer II to lead critical supplier qualification efforts supporting medical device product development and launches. You will collaborate with R&D, Design Assurance, Operations and Regulatory Affairs to ensure quality systems and risk management align with strict regulatory requirements.

Requires a Bachelor’s in engineering or science and 2+ years in supplier quality or manufacturing in a highly regulated environment, with up to 20%

Qualifications

• Bachelor’s degree in engineering or scientific field; highly regulated industry experience.
• Willing to travel up to 15–20%; onsite 100% in Irvine, CA.

Responsibilities

• Facilitate/perform gage studies, process capability studies, and supplier process validations.
• Develop and validate test methods, inspection routines and fixtures (SolidWorks).
• Manage component and supplier qualification from initiation to closure.
• Support Design File requirements for supplied components, subassemblies, devices, and services.
• Create test method procedures and provide training; support Receiving Inspection on test methods and investigations.
• Conduct on-site supplier audits.
• Manage supplier-related non-conformances.
• Manage supplier corrective action requests from initiation to closure.
• Report supplier qualification status at cross-functional project meetings.

Education

Bachelor's degree in engineering or scientific field

Master’s degree

Tools

Gage R&R

Statistical Process Control

Process Capability Studies

GD&T

Job description

Edwards Lifesciences in Irvine, CA, seeks a Supplier Quality Engineer II to lead critical supplier qualification efforts supporting medical device product development and launches. You will collaborate with R&D, Design Assurance, Operations and Regulatory Affairs to ensure quality systems and risk management align with strict regulatory requirements.

Requires a Bachelor’s in engineering or science and 2+ years in supplier quality or manufacturing in a highly regulated environment, with up to 20%