**_Please note this is an "onsite" role, and the successful candidate will be expected to work from our Naperville, IL office._** Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The **Supplier Quality Engineer** is responsible for overseeing the supplier management program within Edwards Lifesciences’ Implantable Heart Failure Management (IHFM) business unit, in compliance with applicable Quality procedures. Will have a strong understanding of Quality Management System (QMS) fundamentals and help to maintain and strengthen Edwards Lifesciences’ IHFM existing culture of quality. This individual is a subject matter expert on the supplier module of the e-QMS software (Grand Avenue), supplier evaluations, investigations and corrective actions associated with supplier-related quality issues, and the recurring activities (such as audits and scorecards) required to maintain control of suppliers in a regulated industry. **How you will make an impact** : + Act as a liaison between Edwards Lifesciences and our suppliers, in the area of quality + Maintain and update the supplier audit system and schedule + Conduct on-site, virtual, and/or desktop supplier audits to drive process standardization, waste elimination, and continuous improvement + Establish specific short- and long-term supplier quality goals + Support problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non-conformances + Partner with Edwards Lifesciences’ IHFM product quality engineers to investigate and resolve supplier-related technical issues in a timely manner to ensure continuity of supply + Maintain supplier performance metrics and scorecards + Develop long-term supplier relationships + Partner with Engineering, Operations, and R&D in the evaluation and qualification of new suppliers, following the Edwards Lifesciences IHFM’s supplier management process and applicable standards and regulations + Strategically lead supplier performance improvement projects to increase supplier capabilities + Assist with management and monitoring of key performance indicators (KPIs) related to supplier quality + Coordinate timely completion of supplier evaluations and supplier control activity records in the Grand Avenue Supplier Module (or applicable e-QMS system) + Comply with internal and external quality requirements for supplier management + Model a culture of quality within the organization **What you’ll need (Required):** + Bachelor's degree in engineering or scientific field **What else we look for (Preferred):** + Experience in supplier quality management, quality engineering, or manufacturing engineering within the medical device industry or another regulated industry + Ability to conduct effective root cause investigations; assessment of corrective action strategies; and effectiveness as applied to NCRs and SCARs + Knowledge of ISO 13485, 21 CFR 820, and/or EU MDR 2017/745 requirements relevant to suppliers + Quality Auditor Certification (ISO 13485 Lead Auditor, ASQ-certified CQA, or similar) + Experience working within e-QMS software, such as Grand Avenue or similar software + Working knowledge of various quality system methodologies, such as 5-why analysis, pareto analysis, Six Sigma, etc. + Proficiency in MS-Office Suite or Google products (Word, Excel, PowerPoint, Gmail, Docs, Sheets) Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For Illinois (IL), the base pay range for this position is $67,000 to $96,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. 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.