Senior Manager, Supplier Quality - Contract Manufacturing (CMO)

Edwards Lifesciences; Irvine (CA); On-site; USD 139,000 - 196,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Manager of Supplier Quality to lead the supplier quality program for CMOs and internal partners. The role ensures product quality, regulatory compliance, and risk mitigation across a portfolio of finished medical devices distributed to market.

The candidate will manage a high‑performing team, influence internal stakeholders, and scale quality systems for new product introductions and early commercialization.

Qualifications

• Bachelor’s Degree in Engineering with at least 8 years of related experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering.
• Highly regulated industry experience.
• Demonstrated people leadership and/or leading cross‑functional teams.

Responsibilities

• Lead supplier quality program across CMOs and internal teams to ensure supplier performance and regulatory compliance.
• Develop and implement supplier quality strategies, including quality agreements, CTQs, control plans and SPC.
• Oversee supplier audits, NCRs, SCARs, CAPAs, and post‑market quality monitoring with CMOs.
• Assess supplier performance against contractual obligations and KPIs.
• Mentor and develop a high‑performing Supplier Quality Engineering team.

Skills

Leadership

Cross-functional collaboration

Supplier Quality

Education

Bachelor’s Degree in Engineering

ASQ certification / Certified Lead Auditor

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 for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

We are seeking a strategic and collaborative Senior Manager, Supplier Quality to lead and evolve our Supplier Quality program supporting Contract Manufacturing Organizations (CMOs). This role will play a critical leadership function within Edwards Supplier Management organization ensuring supplier performance, product quality, and regulatory compliance across a portfolio of finished medical devices distributed directly to market. The successful candidate will lead a high‑performing team of Supplier Quality Engineers while partnering closely with internal stakeholders across Supplier Development, Sourcing, and Business Unit Lifecycle Management teams to strengthen supplier relationships, proactively mitigate risk, and scale quality systems to support both new product introductions and early commercialization. This is a highly visible, high‑touch role requiring strong technical expertise, leadership capability, and the ability to influence both internal teams and external suppliers.

How you will make an impact:

• Manage supplier management project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives utilizing lean manufacturing and error proofing. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow‑up on action items in collaboration with cross functional groups
• Manage and/or oversee the work of a supplier quality team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department
• Identify risk, develop and lead in the implementation of supplier quality strategies which may include negotiations with internal and external parties
• Lead the implementation of quality agreements with suppliers that include requirements for component specifications that details control requirements such as component’s CTQs (Critical to Quality), control plans, SPC (statistical Process Controls) and other continual improvement tools
• Perform complex quality trend analysis from supplier base and facilitate corrective actions as appropriate and effectively address root causes of quality issues.
• Assess supplier performance against contractual obligations, scorecards and key performance indicators
• Other incidental duties

What you will need (Required):

• Bachelor’s Degree in Engineering with at least 8 years of related experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering; or equivalent work experience based on Edwards criteria
• Highly regulated industry experience
• Demonstrated people leadership and/or leading cross‑functional teams

What else we look for (Preferred):

• 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)
• Proven successful project management leadership skills
• Project Management Certification or 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 $139,000 to $196,000 (highly experienced).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.