Supplier Quality Engineer II, Component New Product Development

Edwards Lifesciences seeks a Supplier Quality Engineer II to lead component qualification efforts for surgical products in a fast-paced medical device environment. The role involves managing supplier partnerships, conducting process validations, resolving manufacturing quality issues, and supporting product development timelines while ensuring regulatory compliance.

Responsibilities

• Facilitate and perform gage studies, process capability studies, and supplier process validations based on FMEA risk assessments
• Develop and validate test methods using optical measurement equipment and SolidWorks-designed inspection fixtures
• Manage component and supplier qualification activities from initiation through closure
• Conduct onsite supplier audits, manage non-conformances, and drive corrective action requests to resolution
• Support Design File completion and provide engineering support to Receiving Inspection on test methods and investigations

Requirements

• Bachelor's degree in engineering or scientific field plus 2+ years supplier quality, quality, manufacturing, or production engineering experience
• Master's degree in engineering or scientific field (with or without experience)
• Highly regulated industry experience required
• Ability to travel up to 15–20% and work onsite 100%
• Knowledge of design controls, test method development, and validation
• Proficiency with statistical techniques: Gage R&R, SPC, process capability studies
• Strong root cause analysis and CAPA management skills; GD&T and drawing interpretation ability

Compensation: $87,000–$123,000 base