Designs and installs quality control process sampling systems, procedure and statistical techniques. Designs specific testing mechanism, equipment and devices. Implement and sustain process improvement projects. Works with quality systems for re-engineering.

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.
• 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 focused on controlling the product quality. Supports process improvement plans and strategies that are designed to mitigate the risks identified through Risk Management process
• Support product/process transfer projects to assure compliance with procedures, as well as facilitation of activities required in the transfer.
• 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.
• Analyzes data and interprets standard practices and procedures to establish recommendations for problem solving.
• Responsible for assuring validation / qualification of equipment, (including software) and process following appropriate procedures and meeting regulatory compliance requirements.
• Collaborate and work in the development, implementation and sustaining of the project management program to guarantee projects proper implementation.
• Investigate basic 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
• Work with a multifunctional team to support investigations related to protocol failures based on engineering principles; analyze results and make recommendations.
• Perform other complementary and related duties assigned by the Leadership Team.

Education and Experience:
Bachelor's Degree in Industrial Engineering or a related fieldno experience Required

Additional Skills:
• Good computer skills in usage of MS Office
• Basic documentation, communication and interpersonal relationship skills.
• Basic understanding of statistical techniques.
• Good understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Good problem-solving, organizational, analytical and critical thinking skills.
• Good 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 build stable working relationships internally.
• 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