Supplier Quality Engineer II

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.

This Supplier Quality Engineer will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

How you will make an impact:

• Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCARs (Supplier Corrective Action Reports), CAPAs, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations, and develop reports
• Lead supplier notification of change (NOC) projects, including: having routine meetings with suppliers as needed, lead cross functional team to evaluate the proposed change and create a path for approval, execute the predefined tasks for approving the NOC, properly document the objective evidence for the NOC and acquire relevant approvals.
• Travel to perform Supplier Audits, act as Lead Auditor, and work with the supplier to perform proper root cause analysis to address audit findings using tools such as 5 Whys, DMAIC, PDCA, etc.
• Initiate and participate in the completion of a Product Risk Assessment for relevant complaints.
• Facilitate the development and execution of experiments and tests (including writing or reviewing/approving protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion
• Develop training and documentation materials for production (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes.
• Other incidental duties assigned by Leadership.
  
  

What you'll need (Required):

• Bachelor's degree in in Engineering or Scientific field with at least (2) years of experience in supplier quality, quality engineering, or manufacturing; OR Master's degree in Engineering or Scientific field with no experience (or related internship/co-op experience)
  
  

What else we look for (Preferred):

• Engineering degree
• Highly regulated industry experience
• Experience with supplier quality engineering activities, including partnering with Suppliers
• Manufacturing process controls knowledge and experience (process flow, FMEA, Control plans, Mistake Proofing, Statistical Process Control).
• Experience with CAPAs/SCARs, non-conformances, performing audits, and coordinating notification of changes with manufacturers
• Effective problem-solving techniques (i.e. Root Cause Analysis/Investigations, Corrective Action Strategies, Gage R&R, etc.)
• Ability to read and interpret drawings
• In-depth knowledge of Quality Management Systems and Processes
• Knowledge of DMAIC Six Sigma concepts with ability to apply to work product
• Proven expertise in usage of MS Office Suite
  
  

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.