Principal Supplier Quality Engineer, Contract Manufacturing (CMO)

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

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 a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $121,000 to $171,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).