This position is designated as onsite and requires the successful candidate to work from our corporate campus in Irvine, CA

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

The Supplier Quality Analyst will support new product development supplier quality in the approval, qualification and control of suppliers and purchased goods.  This individual will facilitate compliance with applicable internal and external requirements.  You will work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.  This role will work in close partnership with Quality, R&D, Operations, Sourcing, and Regulatory Affairs.

How you will make an impact:

Evaluate and analyze technical information and data related to quality indicators and recommend course corrections.  Draft presentations and present summaries of trends, potential root causes, and recommended course correctionsCompile data and generate reports for Supplier Quality Engineering and other internal customersDraft updates to Quality procedures and conduct reviews to finalize proceduresCoordinate document, drawing and receiving router changesDevelop technical justifications and other content for Engineering Change Request (ECR) submissionsMaintain and update the Approved Supplier List (ASL), including initiating SARs, coordinating with engineers, managing project priorities, and reviewing content for accuracyConduct monthly and quarterly Quality management metricsDevelop and present training materials for quality system related processesSupport projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires knowledge of organizational objectives.   Other duties assigned by Management, including representing the department in corporate level initiatives.

What You'll Need (Required):

Bachelor's degree

What Else We Look For (Preferred):

Experience working within highly regulated environments: medical device, pharma, biotech, aerospace, automotive, or food industriesExperience with supplier quality, change controls, document controls, change management systems, and/or quality management systemsSkilled in creating dashboards and/or using Power BI, SQL, or similar toolsDemonstrated data analytics/interpretation capabilitiesGood knowledge and familiarity with Good Manufacturing Practices (GMP)Good computer skills in MS Office SuiteGood written and verbal communication skills including negotiating and relationship management skills

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 California (CA), the base pay range for this position is $55,000 to $78,000 (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.