Edwards Lifesciences Supplier Quality Engineer II in Irvine, California
Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures.
Works with suppliers to ensure quality system requirements are understood and successfully met.
Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier and Edwards receiving inspection Test method validation. (pFMEA assessment, IQ, OQ and PQ)
Ensures validation methods of critical 1st and 2nd tier suppliers are aligned with international standards, global regulations, and Industry best practices.
Facilitates risk management activities with suppliers.
Good knowledge of Supplier corrective action report (SCAR) / CAPA elements is required.
Functions as a lead auditor for supplier audit program. (Prior experience not required)
Assesses non-conformances and leads closure of supplier actions as needed.
Manage supplier Notification of changes.
Lead supplier management initiatives.
Education and Experience:
Bachelor's Degree in in Engineering or Scientific field , minimum of 1 years year experience Required or
Master's Degree or equivalent internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education Required
• Good computer skills in usage of MS Office Suite
• Ability to read and interpret drawings
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment is a nice to have.
• Good understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Good problem-solving, organizational, analytical and critical thinking skills
• Good understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.