Senior Manager, Supplier Quality - Contract Manufacturing (CMO)

Edwards Lifesciences•Irvine, CA

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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