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Outset Medical // improving patient care experience
 
Engineering, Full Time    Tijuana, Mexico    Posted: Thursday, September 09, 2021
 
   
 
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JOB DETAILS
 

Company Overview

Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost & complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients &  operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere & by anyone.  The integration of water purification & on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission &  a proprietary data analytics platform powering a new holistic approach to dialysis care.  

 Position Overview

The Senior Supplier Quality Engineer will ensure consistent delivery of high-quality supplies to the business.  The SQE will monitor supplier performance & report results to management, aid in the continual improvement of supplier control plans, & develop & improve supplier quality for a variety of purchased products.

Essential Job Responsibilities

  • Develop Supplier Improvement Plan
  • Ensure Supplier Audit Schedule Compliance
  • Supplier Trend Analysis to develop strategy 
  • Follow Up Corrective Actions, ensuring Root Cause tools are adequate for the issue reported 
  • Support or execute change orders for process improvements & determines when process stability & capability studies should be performed on existing suppliers. 
  • Analyzes and performs failure analysis to non-conforming products. 
  • Review & participates in the Component Qualifications (PPAP), MSA & supplier Control Plans 
  • Provides input to suppliers scorecards. 
  • Manage qualifications of changes & coordinates associated change control activities. 
  • Develops and prepares monthly suppliers quality trend analysis & reports. 
  • Team Member in Supplier Qualification & Maintenance process, including audits.

Requirements/Qualifications

  • Bachelor's degree in engineering or technical field.  
  • Minimum of 7+ years of supplier quality or working with supplier qualification projects  experience in a medical device or other regulated industry is required. 
  • Strong verbal & written communication skills in English is required.
  • Knowledge of medical device regulations & standards such as 21 CFR 820, GMP, EN ISO 13485, & ISO 14971. 
  • Able to read & understand technical data (drawings, GD&T, etc) 
  • Lead Auditor certification a plus. 
  • Lean Certification a plus. 
  • Competent using Microsoft Office suites.  
  • Experience with statistical analysis software a plus.
  • Effective analytical, technical, & problem-solving skills. Applies rigorous methodology to complex problems, including six sigma methodology. 
  • Ability to multi-task & manage multiple assignments in a timely manner. 
  • Good communication & interpersonal skills. 
  • Strong analytical skills. 
  • Sound knowledge of sampling plan & other statistical techniques.
 
 
 
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