We are seeking a highly skilled Senior Manufacturing Quality Engineer to join our team at Edwards Lifesciences. This is an exciting opportunity for a quality professional to apply their expertise in ensuring compliance with regulatory requirements and optimizing product development, internal and external device manufacturing, and device distribution.

Key Responsibilities:

• 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 moderately complex 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 seamless knowledge transfer of project and manufacturing processes.
• Assign support tasks, give instructions to technicians on conducting tests, train technicians, provide feedback, and may coordinate technician work.

• Bachelor's Degree in Engineering or Scientific field, 2 years min. experience Required or Master's Degree or equivalent in Engineering or Scientific field including either industry or industry/education Required.
• Good computer skills in usage of MS Office Suite; CAD experience preferred.
• Good documentation, communication, and interpersonal relationship skills including negotiating and relationship management 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 productive internal/external working relationships.
• 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.