Remote Principal Supplier Quality Engineer, Medical Devices

Edwards Lifesciences Gruppe; Irvine (CA); Remote; USD 121,000 - 171,000; Full time

Job summary

Edwards Lifesciences Gruppe seeks a Principal Supplier Quality Engineer to provide end-to-end quality oversight for CMOs producing finished medical devices. You will monitor supplier performance, lead CAPAs/SCARs, and drive continuous improvement across Edwards and supplier teams.

You will translate design requirements into robust manufacturing controls and support NPI, transfers, and process validation. This senior individual contributor role may be fully remote within the United States, with

Qualifications

• Experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering in a regulated industry.
• Experience with CMOs, audits, NCRs/SCARs, CAPAs and post-market quality monitoring.
• Knowledge of FDA, GMPs, ISO/EN standards and related regulatory requirements.

Responsibilities

• Provide end-to-end quality oversight for CMOs producing finished medical devices.
• Monitor supplier performance using quality metrics, audits, and KPIs; drive CAPAs and continuous improvement.
• Lead supplier quality activities including SCARs, nonconformances, investigations, containment and effectiveness verification.
• Develop supplier quality roadmaps with cross-functional partners; translate Edwards design requirements to supplier processes.
• Support NPI, design transfer, process validation, and production scale-up activities.
• Build strong relationships with CMOs and hold suppliers accountable for quality and compliance.

Skills

Supplier Quality

Quality Engineering

Manufacturing Engineering

Audits

CAPAs

SCARs

NCRs

Root Cause Analysis

FMEA

Control Plans

Statistical Process Control

Lean Manufacturing

DMAIC Six Sigma

Project Management

ASQ Lead Auditor

Regulatory Knowledge

MS Office

Education

Bachelor's degree in engineering or scientific field

Master's degree in engineering or scientific field

Tools

Microsoft Office

Job description

Edwards Lifesciences Gruppe seeks a Principal Supplier Quality Engineer to provide end-to-end quality oversight for CMOs producing finished medical devices. You will monitor supplier performance, lead CAPAs/SCARs, and drive continuous improvement across Edwards and supplier teams.

You will translate design requirements into robust manufacturing controls and support NPI, transfers, and process validation. This senior individual contributor role may be fully remote within the United States, with