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. Directs risk assessment activities as part of process improvements by looking into current issues with product and related manufacturing processes. Further, the quality engineer is developing the quality management system continuously.

Key Responsibilities:
• Develops and maintains methods and sampling procedures for inspections, testing and evaluation. Supports Quality Operations to ensure that products and processes comply with the relevant requirements of the Quality Management System.
• Identify and ensure the optimization of complex Manufacturing and/or R&D 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.
• Responsible for leading multifunctional teams to develop risk assessment activities, as part of Advanced Quality Planning system; creating and maintaining files including Process Map, FMEA and Plans for controlling product quality. Supports process improvement plans and strategies that are designed to mitigate the risks identified through Risk Management process. 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.
• Support product/process transfer projects to assure compliance with procedures, as well as facilitation of activities required in the transfer.
• Responsible for assuring validation / qualification of equipment, (including software) and process following appropriate procedures and meeting regulatory compliance requirements.
• Investigate 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.
• Train, coach, and guide lower level employees on routine procedures.
• Develop and support continuous improvement activities to enhance the 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.
• Collaborate and work in the development, implementation and sustaining of the project management program to guarantee the daily and bi-weekly follow up of the projects activities in order to assure its proper implementation
• Analyzes data and interprets standard practices and procedures to establish recommendations for problem solving.
• wal.
• Other incidental duties

Education and Experience:
Bachelor's Degree in in Engineering or Scientific field, 4 years years experience of previous related experience Required or
Master's Degree or equivalent in in Engineering or Scientific field, 3 years years experience of previous related experience Required or
Ph.D. or equivalent in in Engineering or Scientific fieldno experience Required
CAD experience Preferred
Previous experience working with lab/industrial equipment Preferred

Additional Skills:
• 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