Senior Supplier Quality Engineer, New Product Development

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.  The Senior Supplier Quality Engineer will play a key role on critical new product development projects for our rapidly emerging heart failure monitoring devices.  This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is leading successful part qualification efforts with external suppliers to support Irvine based operations to scale a grow the supplier base capability. The Supplier Quality Engineer will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success. How you will make an impact: Lead/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs. Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks. Assess and own supplier files related to acquisition suppliers and align conformance to Edwards requirements. Manage component and supplier qualification activities from initiation to closure. Supports completion of Design File requirements applicable to supplied components, subassemblies, devices, and services. Create test method procedures and provide training.   Provide engineering support to Receiving Inspection on component test methods and investigations. Conduct on-site supplier audits. Manage supplier-related non-conformances. Manage supplier corrective action requests from initiation to closure. Report on supplier part qualification status at recurring cross-functional project meetings   What you’ll need (Required):   Bachelor’s degree in engineering or scientific field with at least four (4) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities; OR Master’s degree with three (3) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities. Highly regulated industry experience. Must have ability to travel up to 20% What else we look for (Preferred): Engineering degree Medical Device, Aerospace, or Automotive industry experience. Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products. Demonstrated experience driving component testing, test method validations, and testing/validating equipment Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies. In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process IQ/OQ/PQs). Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs. Knowledge of GD&T and ability to read and interpret drawings. Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.). Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety