Senior Supplier Quality Engineer, CMO (Remote)

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

Job summary

Edwards Lifesciences is seeking a Principal Supplier Quality Engineer to oversee quality for contract manufacturers producing finished medical devices. The role acts as a key technical and relationship leader across Quality, Sourcing, Design Engineering, and Operations.

The candidate will develop supplier quality roadmaps, monitor performance, address issues, and drive continuous improvement while ensuring compliance with regulatory requirements.

Qualifications

• Experience in a highly regulated industry (medical devices/pharma) required.
• Proven ability to manage supplier quality for CMOs and drive CAPAs and corrective actions.
• Strong knowledge of quality systems, audits, and regulatory requirements (FDA, GMP, ISO).

Responsibilities

• Provide end-to-end quality oversight for CMOs producing finished medical devices.
• Monitor supplier performance using metrics, scorecards, and audits; drive CAPAs.
• Lead nonconformances, complaint investigations, root-cause analysis, containment, and effectiveness verification.
• Develop supplier quality roadmaps with cross-functional teams (Sourcing, Design, Operations).
• Ensure Edwards design requirements translate into supplier processes and tests.
• Support NPI, design transfer, process validation, and production scale-up.

Skills

Quality engineering

Root cause analysis

Statistical analysis

Project management

Supplier relationship

Audits

Six Sigma

Leadership

Education

Bachelor's degree in engineering or scientific field

Master’s degree in engineering or scientific field

Tools

Microsoft Office

Job description

Edwards Lifesciences is seeking a Principal Supplier Quality Engineer to oversee quality for contract manufacturers producing finished medical devices. The role acts as a key technical and relationship leader across Quality, Sourcing, Design Engineering, and Operations.

The candidate will develop supplier quality roadmaps, monitor performance, address issues, and drive continuous improvement while ensuring compliance with regulatory requirements.