Edwards Lifesciences Principal Engineer, Supplier Quality – Transcatheter Mitral and Tricuspid Therapies in Irvine, California
Job Description & Qualifications
The Principal Supplier Quality engineer is a key role of an innovative and challenging project within Transcatheter Mitral and Tricuspid Therapies. This is a cross-functional position in partnership with the Quality, R&D, and Operations with a primary focus to lead in the development, qualification, improvement, and management of suppliers. The Principal Quality Engineer will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
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
Lead 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 unusually 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
Train, coach and mentor Quality Engineers as a subject matter expert in key technical areas
Communicate supplier quality risks to upper management during Management Review and Project Meetings, and identify solutions to mitigate risks.
Support process and system improvement projects as assigned by manager
Bachelor’s degree in engineering with a minimum 10 years’ experience or master’s degree plus 8 years’ experience in medical device manufacturing (preferred) or other regulated industry
Strong knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards preferred
Knowledge of complex catheter and implant manufacturing preferred
Demonstrated engineering experience in Supplier Quality, Supplier Development, New Product Development, or Manufacturing Engineering in medical device or other regulated industry
Thorough understanding of risk management principles and techniques
Experience with the use of statistical techniques, Six Sigma tools, and DMAIC problem solving techniques.
Strong problem solving and critical thinking skills.
Ability to effectively communicate across different levels of the organization
Ability to work independently without close supervision
Ability to manage competing priorities in a fast paced environment
Good leadership and interpersonal skills, with the ability to negotiate and influence change.
Possess the ability to multi-task, while maintaining high attention to detail
Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers)
ASQ Certified Quality Manager, Quality Engineer, Quality Systems Lead Auditor or related quality or regulatory certifications a plus
Ability to travel up to 25%.
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.