Design and install sampling systems for quality control processes as well as procedures and statistical techniques. Design a specific test mechanism, equipment and devices. Responsible for implementing and maintaining process improvement projects. In addition, the quality engineer is continually developing the quality management system; including the analysis of complaints or reports of non-compliance and provide support to update the technical files, as well as the analysis of the data related to the manufacturing process.

　　Key Responsibilities:

　　• Cooperate with suppliers in new quality specification projects and coordinate quality improvement programs in all functional areas.

　　• Develop and maintain sampling methods and procedures for inspections, tests and evaluations. Support quality operations to ensure that products and processes comply with the relevant requirements of the Quality Management System.

　　• Develop, adapt / revise methods of inspection, testing and documentation.

　　• 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 prevent recurrence, and also identify and implement preventive actions for process improvements.

　　• Supervise, manage and support quality engineers to ensure compliance with quality systems.

　　• Lead and manage the inspectors in the implementation of a quality policy and achieve quality objectives.

　　• Help develop processes to ensure that the quality, cost and efficiency requirements are met.

　　• Read and interpret written documentation, drawings, procedures and product information.

　　• Continuously improve and give quality assurance in the process and inspection procedures that are received.

　　• Lead multifunctional teams to develop risk assessment activities, as part of the Quality System; create and maintain files, including Process Map, FMEA and Quality Control Plans. It supports plans and strategies to improve processes designed to mitigate the risks identified through the risk management process.

　　• Work with product / process transfer projects to ensure compliance with the procedures, as well as facilitation of the activities required in the transfer related to the Reception area.

　　• Support the activities related to the risk assessment of the product for non-compliant distributed products.

　　• 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

　　Education and Experience:

　　Bachelor's Degree in Industrial Engineering, Mechanical or related field, 4 years of previous related experience required or

　　Master's Degree or equivalent in Industrial Engineering, Mechanical or related field, 3 years of previous related experience required or

　　Ph.D. or equivalent in Industrial Engineering, Mechanical or related field no experience required.

　　Previous experience working with lab/industrial equipment preferred.

　　Additional Skills:

　　• Advanced computer skills that include MS Office; JDE preferred

　　• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.

　　• Substantial knowledge and understanding of statistical techniques.

　　• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.

　　• Strong problem-solving, organizational, analytical and critical thinking skills.

　　• Substantial 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.

　　• Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.

　　• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.

　　• Ability to comply with the standards, regulations, procedures and quality manuals applicable to Edwards Lifesciences.

　　• 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

　　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 15,000 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.