Sr Engineer Supplier Quality, Critical Care

Job Description

For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.  

With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.  

As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability. We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians, and expand into new care settings.     

So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-lifetime’ journey to improve the quality of care and outcomes for millions of patients around the world.  

Appendix:  

For further detail on the spin-off of Critical Care from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99. 

Job Description:

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:
• Advance