Edwards Lifesciences Staff Engineer, Supplier Quality – Transcatheter Mitral and Tricuspid Therapies in Irvine, California
The Staff Supplier Quality Engineer will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & life-saving medical devices. This individual will facilitate compliance to applicable internal and external requirements. You will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with R&D, Marketing, Operations, Sourcing, and RA.
Lead part and supplier qualification activities in compliance with Edwards’s QMS requirements
Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, and component capability assessments
Support risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers
Support suppliers in the development, approval and execution of process validation protocols and reports for critical processes
Perform audits of Quality Systems and Processes at suppliers of materials, components, sub-assemblies, and services.
Analyze and support the effective resolution of complex manufacturing and compliance issues at suppliers resulting from audit observations, incoming/process non-conformance reports, and customer complaints
Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities
Collect and analyze Quality metrics relating to Supplier Quality
Guide quality engineers as a subject matter expert in technical areas
Communicate supplier quality risks to management or internal teams during reviews and project meetings, and identify solutions to mitigate risks.
Support process and system improvement projects as assigned by manager
Bachelor degree in technical or science field with a minimum 5 years’ experience or master’s degree plus 4 years’ experience in medical device manufacturing.
Knowledge and understanding of FDA and international regulatory standards for medical devices is required.
This role involves management of multiple and frequently changing projects and priorities. Highly developed time management, communication, and documentation skills are required.
Excellent documentation and communication skills and interpersonal/intercultural relationship skills including influencing, negotiating and relationship management skills.
Ability to work independently without close supervision.
Advanced understanding of V&V, statistical techniques, test method development, and risk management.
Demonstrated ability to apply statistical quality engineering tools in a supplier environment is required.
Ability to read and interpret drawings.
Serves as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects.
ASQ Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE), or related quality certifications preferred.
General understanding of plastic manufacturing or metal fabrication methods are a plus.
Experience with Class III medical devices required, and experience with implantable devices preferred
Domestic and international travel is required. Expected 25% travel.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.