Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Quality Engineer I position is a unique career opportunity that could be your next step towards an exciting future. This Quality Engineer I will support first shift in the Metals manufacturing area. They will support the day-to-day activities for production, will have responsibilities for documentation on NCRs and CAPAs, do root cause investigations, and will be part of a core team that supports all line improvement projects and validation activities. They will utilize knowledge of manufacturing processes and quality control systems to drive process improvements and resolve quality issues, while ensuring regulatory compliance. **How You'll Make an Impact:** + 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. + 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. + May 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 coordinates technician work + Other incidental duties assigned by Leadership **What You'll Need (Required):** + Bachelor’s degree in Engineering or a scientific field, no prior work experience required **What Else We Look For (Preferred):** + Good computer skills in usage of MS Office Suite; CAD experience preferred + Basic documentation, communication and interpersonal relationship skills + Basic understanding of statistical techniques + Previous experience working with lab/industrial equipment preferred + 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 + Must be able to work in a team environment, including immediate supervisor and other team members in the section or group + Ability to build stable working relationships internally + 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 Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.