Senior Supplier Quality Engineer, Product Development

Overview

Please note this is an onsite role, and the successful candidate will be expected to work from our Draper, UT facility.

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 Senior Supplier Quality Engineer will play a key role on critical new product development projects for metals. 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 will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.

• Bachelor’s degree in Engineering or Scientific field with at least four (4) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities; OR Master’s degree with three (3) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities.
• Highly regulated industry experience.
• Must have ability to travel up to 20%

• Engineering degree
• Medical Device, Aerospace, or Automotive industry experience.
• Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.
• Demonstrated experience driving 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.
• In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process IQ/OQ/PQs).
• Ability to conduct effective root cause analysis; driving 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.
• Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).

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.