Principal Supplier Quality Engineer – CMO (Remote)

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

Job summary

Edwards is seeking a Principal Supplier Quality Engineer to oversee CMOs producing finished medical devices and ensure quality and compliance across the supply chain. This senior role partners with Quality, Sourcing, Design Engineering, and Operations to drive risk reduction and continuous improvement.

The position is fully remote in the United States with some travel to supplier sites and Edwards locations as needed.

Qualifications

• Extensive experience in supplier quality engineering or quality management within a highly regulated environment.
• Strong knowledge of FDA, GMPs and ISO/EN standards is preferred.

Responsibilities

• Provide end-to-end quality oversight for CMOs producing finished medical devices.
• Monitor supplier performance using quality metrics, audits, and KPIs; drive corrective actions and continuous improvement.
• Lead supplier quality activities including CAPAs, SCARs, nonconformances, and root-cause analysis.
• Develop supplier quality roadmaps with cross-functional partners (Sourcing, Design Engineering, Operations).
• Build strong relationships with CMOs and ensure accountability for quality and improvements.
• Support NPI, manufacturing transfer, process validation, and early commercialization activities.
• Analyze supplier quality trends to identify risks and drive improvements using quality tools.

Skills

Quality engineering

Project management

CAPA management

Audit experience

DMAIC Six Sigma

Regulatory knowledge

Education

Bachelor's degree in engineering

Master’s degree in engineering

Tools

MS Office

QMS software

Job description

Edwards is seeking a Principal Supplier Quality Engineer to oversee CMOs producing finished medical devices and ensure quality and compliance across the supply chain. This senior role partners with Quality, Sourcing, Design Engineering, and Operations to drive risk reduction and continuous improvement.

The position is fully remote in the United States with some travel to supplier sites and Edwards locations as needed.