Principal Supplier Quality Engineer, Contract Manufacturing (CMO)

Edwards Lifesciences; United States; A distancia; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Edwards Lifesciences is seeking a Principal Supplier Quality Engineer to provide quality oversight for CMOs producing finished medical devices. The role collaborates with Quality, Sourcing, Design Engineering, Operations and Business Units to address supplier risks and drive continuous improvement.

The position, based in the United States and fully remote eligible, leads CAPAs, SCARs, audits, and supplier evaluations while ensuring compliance with FDA, GMP and ISO standards.

Formación

• Bachelor's degree in engineering or scientific field with at least 6 years of related experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering.
• Master's degree in engineering or scientific field with at least 5 years of related experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering.

Responsabilidades

• Provide end-to-end quality oversight for assigned CMOs producing finished medical devices, including products shipped directly from the supplier to distribution.
• Monitor supplier performance through quality metrics, scorecards, audits, and KPIs; identify risks and drive timely corrective actions and continuous improvement.
• Lead supplier quality activities including CAPAs, SCARs, nonconformances, investigations, root cause analysis, containment, and effectiveness verification.
• Develop and execute supplier quality roadmaps with cross-functional stakeholders to address risks and performance gaps.
• 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, and test methods.
• Provide Supplier Quality support for new product introduction, design and manufacturing transfer, process validation, and production scale-up.
• Analyze supplier quality and manufacturing trends to identify risks and lead improvements using quality engineering tools (FMEA, control plans, SPC, Lean, RCA).
• Support development and improvement of processes for managing finished-device CMOs, especially when products move directly to distribution without Edwards touchpoints.

Conocimientos

Supplier Quality

Quality Engineering

CAPA & SCARs

Audits

Risk Management

Educación

Bachelor's degree in engineering or scientific field

Master's degree in engineering or scientific field

Herramientas

MS Office Suite

Quality tools (Minitab)

Excel

Descripción del empleo

Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision-making throughout a product's lifecycle. Your work will involve optimizing product development and manufacturing performance to impact patients around the world with pioneering technology.

We are seeking a strategic and highly experienced Principal Supplier Quality Engineer to provide quality oversight for Contract Manufacturing Organizations (CMOs) producing finished medical devices.

This senior individual-contributor role will serve as a key 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 will establish supplier quality roadmaps, monitor supplier performance and risk, address quality and compliance issues, and ensure suppliers remain accountable for corrective actions and continuous improvement commitments.

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

How you will make an impact:

• Provide end-to-end quality oversight for assigned CMOs producing finished medical devices, including products shipped directly from the supplier 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 in partnership with Sourcing, Design Engineering, Operations, and other cross-functional stakeholders to address supplier risks, performance gaps, and strategic priorities.
• Build strong, high-touch 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 effectively 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 activities.
• 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 where products move directly to distribution without an Edwards manufacturing touchpoint.
• Other incidental duties.

What you will need (Required):

Bachelor's degree in engineering or scientific field with at least 6 years of related experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering, OR Master's degree in engineering or scientific field with at least 5 years of related experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering. Highly regulated industry experience.

What else we look for (Preferred):

• Engineering degree
• Medical Device or Pharma industry experience
• Experience overseeing and managing Suppliers or CMOs, including managing audits, NCRs, SCARs, CAPAs, complaint investigations, post-market quality monitoring and notification of changes with suppliers
• Experience supporting Contract Manufacturing Organizations (CMOs) producing finished medical devices, including accountability for end-to-end product quality and performance
• Experience with electronics, PCBA, or electro-mechanical assemblies
• Manufacturing process controls knowledge and experience (process flow, Lean Manufacturing, FMEA, Control plans, Statistical Process Control,).
• In-depth knowledge of domestic and international regulatory requirements (e.g., FDA, 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 knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering
• ASQ certification / Certified Lead Auditor
• Proven expertise in both Microsoft Office Suite and related systems

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and