Edwards is looking to improve its product development, manufacturing, and distribution processes by ensuring compliance with regulatory requirements and internal systems through a Supplier Quality Engineer.
Requirements
- 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
Responsibilities
- 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 the seamless knowledge transfer of project and manufacturing processes.
Other
- onsite role based in Draper, Utah
- 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 experience)
- Highly regulated industry experience
- Proven expertise in usage of MS Office Suite
- COVID-19 vaccination
