Principal Supplier Quality Engineer, Contract Manufacturing (CMO)

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

Job summary

Edwards Lifesciences Gruppe seeks a Principal Supplier Quality Engineer to provide end-to-end quality oversight for CMOs producing finished medical devices. You will monitor supplier performance, lead CAPAs/SCARs, and drive continuous improvement across Edwards and supplier teams.

You will translate design requirements into robust manufacturing controls and support NPI, transfers, and process validation. This senior individual contributor role may be fully remote within the United States, with

Qualifications

• Experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering in a regulated industry.
• Experience with CMOs, audits, NCRs/SCARs, CAPAs and post-market quality monitoring.
• Knowledge of FDA, GMPs, ISO/EN standards and related regulatory requirements.

Responsibilities

• Provide end-to-end quality oversight for CMOs producing finished medical devices.
• Monitor supplier performance using quality metrics, audits, and KPIs; drive CAPAs and continuous improvement.
• Lead supplier quality activities including SCARs, nonconformances, investigations, containment and effectiveness verification.
• Develop supplier quality roadmaps with cross-functional partners; translate Edwards design requirements to supplier processes.
• Support NPI, design transfer, process validation, and production scale-up activities.
• Build strong relationships with CMOs and hold suppliers accountable for quality and compliance.

Skills

Supplier Quality

Quality Engineering

Manufacturing Engineering

Audits

CAPAs

SCARs

NCRs

Root Cause Analysis

FMEA

Control Plans

Statistical Process Control

Lean Manufacturing

DMAIC Six Sigma

Project Management

ASQ Lead Auditor

Regulatory Knowledge

MS Office

Education

Bachelor's degree in engineering or scientific field

Master's degree in engineering or scientific field

Tools

Microsoft Office

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 degreeMedical Device or Pharma industry experienceExperience overseeing and managing Suppliers or CMOs, including managing audits, NCRs, SCARs, CAPAs, complaint investigations, post-market quality monitoring and notification of changes with suppliersExperience supporting Contract Manufacturing Organizations (CMOs) producing finished medical devices, including accountability for end-to-end product quality and performanceExperience with electronics, PCBA, or electro-mechanical assembliesManufacturing 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 conceptsIn-depth knowledge of Quality Management Systems and ProcessesExtensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality EngineeringASQ certification / Certified Lead AuditorProven expertise in both Microsoft Office Suite and related systemsAligning 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). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.