**Please note this is an onsite role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.

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 Engineer II will play a key role on a critical project within the Transcatheter Heart Valve (THV) business unit. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is leading successful part qualification efforts with external suppliers to support product development and commercial launch timelines. The Supplier Quality Engineer II will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.

How you will make an impact:

Facilitate/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAsDevelop non-complex test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorksManage component and supplier qualification activitiesCreate test method procedures, and train and provide engineering support to Receiving Inspection on component test methodsConduct on-site supplier auditsManage supplier-related non-conformancesManage supplier corrective action requests from initiation to closureReport on supplier part qualification status at recurring cross-functional project meetingsProvide feedback to R&D and Design Assurance on supplier process output/performance and ability to measure and validate critical features on drawings
 

What you’ll need (Required Qualifications):

Bachelor’s degree in Engineering or Scientific field with at least 2 years of experience with supplier quality, manufacturing, or quality engineering functions; OR Master’s degree with no experience (or internship experience)Highly regulated industry experienceMust have ability to travel up to 25%

What else we look for (Preferred Qualifications):

Engineering degreeMedical Device industry experienceExperience with supplier quality engineering activities, including external supplier vendor auditsAbility to conduct effective root cause investigations; assessment of corrective action strategies; and effectiveness as applied to NCRs and SCARs Proficient knowledge of Design Controls and test method development/validationExperience with Class II and/or Class III medical devicesKnowledge of GD&T and ability to read and interpret drawingsStrong understanding of process validation (IQ, OQ, PQ)Strong understanding with Gage R&R/measurement system analysis and process capabilityStrong understanding of risk management principlesStrong understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.)Strong understanding of statistical techniques for new product development and MinitabStrong understanding of Quality Management System requirementsStrong communication and organization skillsASQ Certified Quality Engineer, Quality/Biomedical Auditor, or Six Sigma Black BeltKnowledge and understanding of FDA and international regulatory standards for medical devicesAbility to work independently without close supervision

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 $85,000 to $120,000 (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.