Supplier Quality Engineer I, Component New Product Development

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 will play a key role in supporting critical projects within the Surgical business unit.  This position is cross-functional in nature and will collaborate and establish partnerships with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is assisting with part qualification efforts with external suppliers to support product development and commercial launch timelines.  The Supplier Quality Engineer 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:

• Support gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs.
• Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
• Assist with component and supplier qualification activities from initiation to closure.
• Support completion of Design File requirements applicable to supplied components, subassemblies, devices, and services.
• Provide engineering support to Receiving Inspection on component test methods and investigations.
• Manage supplier-related non-conformances.
• Manage supplier corrective action requests from initiation to closure.
• Report on supplier part qualification status at recurring cross-functional project meetings

What you’ll need (Required Qualifications):

• Bachelor’s degree in Engineering or Scientific field

What else we look for (Preferred Qualifications):

• Engineering degree
• Medical Device, Aerospace, or Automotive industry experience.
• Co-op or internship experience within a highly regulated industry working within either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering.
• Experience with supplier/vendor management and qualification activities with suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.
• Knowledge of component testing, test method validations, and testing/validating equipment
• Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies.
• Understanding of risk management for validation qualifications (e.g. equipment or process IQ/OQ/PQs).
• Ability to conduct effective root cause analysis, non-conformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs.
• Knowledge of GD&T and ability to read and interpret drawings.
• Understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).

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 $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