Engr I, Supplier Quality

**Key Responsibilities**:

- Develop and maintain sampling methods and procedures for inspections, testing and evaluation. It supports Quality Operations to guarantee that the products and processes comply with the relevant requirements of the Quality Management System
- Work with a multifunctional team in the evaluation and approval of new suppliers.
- Review and approve feasibility studies, process / product changes, technical reports, product transfers, market and clinical trial plans, and protocol reports
- Work with a multifunctional team to support investigations of nonconformities to identify the root cause in a timely manner and recommend provision and corrective actions to avoid recurrence.
- Works closely with suppliers and buyers as appropriate in the resolution of supplier quality problems.
- Support activities related to the evaluation of product risks for non-compliant distributed products.
- Develop and support supplier audits.
- Maintain documentation related to the provider's quality system requirements.
- Work with process transfer projects to ensure compliance with the procedures, as well as the facilitation of the supplier qualification.
- Develop and support ongoing improvement activities to improve Quality Systems, using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, SPC, Kaizen Lean methods, DOE, etc.
- Other incidental duties assigned by Leadership

**Education and Experience**:
Bachelor's Degree or Equivalent in Engineering or Scientific field, no experience required or Master's Degree or equivalent in Engineering or Scientific field, no experience required

**Additional Skills**:

- Good computer skills in usage of MS Office Suite
- Ability to read and interpret drawings
- Basic documentation, communication and interpersonal relationship skills
- Basic understanding of statistical techniques
- Previous experience working with lab/industrial equipment preferred
- 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 immediate supervisor and other team members in the section or group
- Ability to build stable working relationships internally
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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

About Edwards Lifesciences

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.

COVID Vaccination Requirement

**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

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