For over 50 years, the Critical Care product group 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.  

If you're a dynamic and passionate person who is eager to contribute to innovative, industry-leading advanced technology, we invite you to explore our career opportunities.

We believe those who join us will be part of an inspiring journey to improve the quality of care for millions of patients around the world.  

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On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX).  It remains business as usual at Edwards until the transaction closes. More information on Edwards’ announcement about the acquisition can be found here:

https://www.edwards.com/newsroom/news/2024-06-03-edwards-lifesciences-to-sell-critical-care-to-bd

Responsible for investigating, analyzing and correcting quality, production and control problems in the location of a supplier. They can also perform audits and implement new strategies related to the management of suppliers.

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
• 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.
• Work with a multifunctional team in the evaluation and approval of new suppliers.
• 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 product / process transfer projects to ensure compliance with the procedures, as well as the facilitation of the activities required in the transfers.
• 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, 2 years of previous related experience Required

Additional Skills:
• Good computer skills in the use of MS Office Suite; JDE preferred
• Good documentation and interpersonal relationship skills
• Good written and verbal English communication skills.
• Solid problem-solving, organizational, analytical and critical thinking skills
• Basic knowledge of statistical techniques
• Solid knowledge of principles, theories and concepts relevant to Engineering
• Solid knowledge of the processes and equipment used in the assigned work
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage multiple tasks in a timely manner
• Ability to work independently and as part of a team.
• 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