Make a meaningful difference to patients around the world.
At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives.
As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality.
Your purpose-driven work will help leave lasting and positive impacts on patient lives.
The Role The Quality Engineer II applies 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.
How Will You Make An Impact?
Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports Optimize manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk Develop, update, and maintain technical content of risk management files Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work What You Will Need?
A Bachelor's degree in Engineering or a Scientific field Minimum of 2 years' experience in Quality or Manufacturing is required What Else We Require?
Good computer skills in usage of MS Office Suite; CAD experience preferred Good documentation, communication and interpersonal relationship skills Basic understanding of statistical techniques Previous experience working with lab/industrial equipment required Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering Solid problem-solving, organizational, analytical and critical thinking skills Solid 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 stable working relationships internally 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