Supplier Quality Engineer

Alpharetta, Georgia | Quality Assurance / Safety

Supplier Quality Engineer, Medical Device

 

Our client is a 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, 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 hands-on in their experience with suppliers and involved with multiple projects at each supplier
  • Operates as an individual contributor when visiting suppliers, managing Audits, Root Cause investigations, and CAPA resolution
  • Is centrally involved in the identification, approval, onboarding, and auditing of new suppliers
  • Supports the integration of new manufacturing processes
  • Provides mentoring/coaching in Risk Analysis, e.g. PFMEA as it applies to existing and NPD, at suppliers
  • Knows Lean/Six Sigma principles including, at a minimum, DOE, SPC, PFMEA, and Process Capability
  • 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
  • Interacts with Purchasing to ensure Supplier Performance Criteria are clearly defined via Agreements and being met through Performance Metric Measurement

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. Strong Knowledge 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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