Senior Manager, Supplier Quality - New Product Development

About the role

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. This Irvine based Senior Manager, Supplier Quality is responsible for overseeing a team along with supplier and receiving inspection activities for qualifying components in support of development, transfer, and launch of new Aortic transcatheter valve replacement delivery system devices. We are seeking a strong, highly collaborative engineering leader with solid technical expertise who enjoys working in a fast-paced and rapidly growing environment. The ideal candidate will combine people leadership with deep expertise in component qualification, validation, and data analysis, while partnering cross-functionally with R&D, Regulatory, Design Assurance, Manufacturing Engineering, Program Management, and global Receiving & Inspection teams. This is a high-impact role requiring strong influencing skills to navigate complex stakeholder environments, drive alignment, and ensure suppliers consistently meet quality and regulatory expectations. How you will make an impact : Provide oversight and mentorship for supplier quality engineers who are responsible for working with new product development teams and supplier development engineers on integrating new components and suppliers into the Edwards quality system. The supplier quality engineers currently support component specification development, identification of critical features, development of inspection methods and plans, test method validation, component capability assessment, and validation of outsourced critical processes. Drive portions of a project, including acting as the project manager for all Supplier Quality tasks in support of the Edwards new product development process and project milestones, and reporting on status of deliverables at cross-functional project forums. Lead team in validating suppliers, which includes supplier process validations and supplier reviews. Participate in technical discussions with suppliers to identify and implement improvements in products and processes. Support manufacturing readiness reviews, supply chain readiness reviews, manufacturing transfers and develop plans for the set-up and transfer of components between facilities Lead team in supporting drawing reviews to ensure inspection DFX considerations are incorporated into designs. Report test method outputs of component critical features and drive/influence drawing changes where warranted. Lead the implementation of new or updated 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), ROC (Receive on Certification) and other continual improvement tools. Work with and provide oversight to suppliers on the design and procurement of components, tooling and fixtures for the design, testing, inspection or assembly of products. Ensure supplier files associated with the suppliers utilized on new products comply with Edwards' supplier qualification requirements. Lead quality continuous improvement initiatives, including quality system and procedure adjustments, to elevate quality, compliance, and efficiency of the supplier qualification process. Perform audits of approved suppliers' quality management system and act as Supplier Quality subject matter expert on cross-functional technical assessments of suppliers that are being considered for addition to the approved supplier list. Provide technical input for supplier selection, including evaluation of supplier capability, part qualification plan requirements, specification review, product implementation and part transition to manufacturing. Manage investigation and risk-based escalation of non-conformance issues. Manages staff development, ethics and motivation through appropriate assignment of opportunities and training activities to support the achievement of both professional development goals and business goals Responsible for ensuring successful completion of all deliverables in accordance with project plans and established timelines, including in fast-paced or accelerated schedules. What you will need (Required) : Bachelor's degree with at least 8 years of experience in Supplier Quality, Manufacturing, New Product Development/Introduction, and/or Quality Engineering functions; or equivalent work experience based on Edwards' criteria. Experience working within a highly regulated industry Demonstrated people leadership experience and/or leading cross-func

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