Quality Engineer II

A Quality Engineer II applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimise product development, internal and external device manufacturing, and device distribution.How You Will Make An Impact:Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyse results, make recommendations, and develop reports. (R&D: 30)Develop, update, and maintain technical content of risk management filesInvestigate 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; analyse results, make recommendations and develop reports. (MFG: 45 / R&D: 15)Optimize to 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 riskDevelop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processesAssign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.Other incidental duties assigned by LeadershipWhat You Will Need:Bachelor's Degree in in Engineering or Scientific field , 2 years experience Required What Else We Look For:Good computer skills in usage of MS Office Suite; CAD experience preferredGood documentation, communication and interpersonal relationship skills including negotiating and relationship management skillsBasic understanding of statistical techniquesPrevious experience working with lab/industrial equipment requiredSolid understanding and knowledge of principles, theories, and concepts relevant to EngineeringSolid problem-solving, organizational, analytical and critical thinking skillsSolid understanding of processes and equipment used in assigned workKnowledge of and adherence to Quality systemsStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including the ability to manage vendors and project stakeholdersAbility to build productive internal/external working relationshipsAdhere 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