Principal Supplier Quality Engineer, Contract Manufacturing (CMO)

Edwards Lifesciences • Irvine, CA

2d • Remote

About The Position

The Principal Supplier Quality Engineer provides quality oversight for Contract Manufacturing Organizations (CMOs) producing finished medical devices. This senior individual-contributor role serves as a technical and relationship leader between Edwards, its CMOs, and internal stakeholders across Quality, Sourcing, Supplier Development, Design Engineering, Operations, and Business Unit teams. The role establishes supplier quality roadmaps, monitors supplier performance and risk, addresses quality and compliance issues, and ensures suppliers remain accountable for corrective actions and continuous improvement commitments.

The position is eligible to be fully remote within the United States. Travel to suppliers and Edwards’ locations may be required based on business needs.

Requirements

• Bachelor's degree in an engineering or scientific field and at least 6 years of related experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering; OR a master's degree in an engineering or scientific field and at least 5 years of related experience in those fields.
• Experience in a highly regulated industry.

Nice To Haves

• Engineering degree.
• Medical device or pharmaceutical industry experience.
• Experience overseeing and managing suppliers or CMOs, including audits, NCRs, SCARs, CAPAs, complaint investigations, post-market quality monitoring, and supplier change notifications.
• Experience supporting CMOs producing finished medical devices, including accountability for end-to-end product quality and performance.
• Experience with electronics, PCBA, or electromechanical assemblies.
• Knowledge and experience with manufacturing process controls, including process flow, Lean Manufacturing, FMEA, control plans, and Statistical Process Control.
• In-depth knowledge of domestic and international regulatory requirements, such as FDA requirements, GMPs, and ISO/EN standards.
• Demonstrated project leadership and stakeholder-management skills.
• Project management certification or equivalent project leadership experience.
• Knowledge of DMAIC Six Sigma concepts.
• In-depth knowledge of Quality Management Systems and processes.
• Extensive understanding of principles, theories, and concepts relevant to Quality Engineering.
• ASQ certification or Certified Lead Auditor qualification.
• Proven expertise in Microsoft Office Suite and related systems.

Responsibilities

• Provide end-to-end quality oversight for assigned CMOs producing finished medical devices, including products shipped directly from suppliers to distribution.
• Monitor and assess supplier performance through quality metrics, scorecards, complaint trends, audits, and key performance indicators; identify risks and drive timely corrective actions and continuous improvement.
• Lead supplier quality activities, including CAPAs, SCARs, nonconformances, complaint investigations, root cause analysis, containment, and effectiveness verification.
• Develop and execute supplier quality roadmaps with Sourcing, Design Engineering, Operations, and other cross-functional stakeholders to address supplier risks, performance gaps, and strategic priorities.
• Build strong relationships with CMOs and hold suppliers accountable for quality, compliance, performance, and improvement commitments.
• Partner with suppliers and internal teams to ensure Edwards design requirements are translated into supplier manufacturing processes, controls, specifications, and test methods.
• Provide Supplier Quality support for new product introduction, design and manufacturing transfer, process validation, early commercialization, and production scale-up.
• Analyze supplier quality and manufacturing trends to identify emerging risks and lead improvements using quality engineering tools such as FMEA, control plans, Statistical Process Control, Lean, and structured root cause analysis.
• Support the development and continuous improvement of processes for managing finished-device CMOs, particularly when products move directly to distribution without an Edwards manufacturing touchpoint.
• Perform other incidental duties.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Principal