Senior Manager, Supplier Quality - New Product Development

Edwards Lifesciences•Irvine, CA

11d•$139,000 - $196,000•Onsite

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. 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.

Requirements

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-functional teams.
Ability and willingness to travel between 10 – 25% domestically and internationally (mostly domestic).

Nice To Haves

Medical device industry experience.
Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.
Experience with CAPAs, NCRs, change notifications, and/or auditing within a highly regulated environment.
Demonstrated experience driving test method development (TMD), and validation of test methods and equipment (e.g., TMVs).
Experience with CAD as it relates to component and fixture design, inspection strategies, or test method development.
Strong knowledge of DFM/DFx, component design reviews, and manufacturing capability assessment.
Hands-on experience with supplier validations, including IQ/OQ/PQ, process validation, and capability studies.
Proven ability to evaluate supplier technical capabilities, including auditing, risk assessments, and capacity reviews.
Experience supporting or leading new product introduction (NPI), design transfer activities, and manufacturing readiness evaluations.
Proficiency in statistical analysis and use of quality tools (Six Sigma, DMAIC, DOE, SPC, Gage R&R, pFMEA, dFMEA, etc.).
Demonstrated ability to troubleshoot complex quality issues and drive root cause & corrective action.
Knowledge of manufacturing processes for molding, extrusions, machining, metals, textiles, or catheter sub-assemblies.
Knowledge and understanding of FDA and international regulatory standards (e.g., 21 CFR 820, ISO 13485 & ISO 14971) for medical devices.
Demonstrated project management experience, with the ability to manage multiple priorities in a fast-paced environment
Strong negotiation, influencing, and stakeholder management skills, with the ability to appropriately challenge and push back to drive quality outcomes
ASQ CQE, CQA, Six Sigma Green Belt or Black Belt certification

Responsibilities

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.
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.