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Senior Supplier Quality Engineer

Dallas, Texas | Quality Assurance / Safety

Senior Supplier Quality Engineer, Medical Device

Our client is a closely held Medical Device manufacturer.  Their growth has been extremely good and as described by the HA “There is a lot of enthusiasm for what we do here; it’s a truly great place to work or I wouldn’t be here!” 

 

As an SQE you are expected to hit the ground running, fully capable of managing your own projects and experienced enough to move beyond the “Silo” approach.  You will be challenged every day across the breadth of the demands of a device QS as it relates to Supplier Quality.  What this means is that your knowledge in ISO 13485 and the importance it places on this component of the QS will be critical. 

 

RESPONSIBILITIES:

  • Assures compliance to Supplier Quality regulations per ISO and FDA requirements
  • Is centrally involved in the identification, approval, onboarding, and auditing of new suppliers
  • Supports the integration of new manufacturing processes
  • Provides for the continuity of Supplier Process Control & Inspection procedures to the employer’s
  • Provides mentoring/coaching in Risk Analysis, e.g. PFMEA as it applies to existing and NPD
  • Is a leader in Lean/Six Sigma type principles including, at a minimum, DOE, SPC, PFMEA, Process Capability and, Root Cause
  • Develops, improves, and/or assists in the development of CTQ indices and KPI’s reporting results to NPD, Operations teams, Suppliers, or management as required
  • Assists as a critical team member during 3rd party inspections internally and at suppliers
  • Works closely with the Supply Chain team to ensure that Suppliers meet the needs of common criteria and that criteria are confirmed with onsite audits on a predefined calendar

REQUIREMENTS:

  1. Bachelor’s Degree in an appropriate Engineering or other technical discipline
  2. Certifications including ASQ (e.g. CQA or CQE) and CSSBB are highly valued
  3. 5+ years as a Quality Engineer with demonstrable experience in Supplier Management and Auditing
  4. History in Supplier Development, Validation, and Improvement
  5. Strong foundational knowledge in ISO 13485 and 21 CFR 820
  6. Excellent experience in the Microsoft Office Suite, MS Project and SolidWorks
  7. Background in machining, casting/forging, and 3-D manufacturing as they relate to med device
  8. Demonstrable skills in the application of Lean, Six Sigma, and SPC
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