24861 Engineer, Sr Supplier Quality – Osseo

This Sr. Supplier Quality Engineer provides support for all Supplier Quality related activities. It also assists in Receiving Inspection operations, supplier survey/ audit responsibilities, and new product development operations.

Key Responsibilities include:

• Monitor, analyze, and report on supplier performance to provide key performance information to the department manager, senior management, and outside departments.
  
• Assist suppliers in formation of statistical sampling plans, inspection methodology, and procedures.
  
• Provide technical consultation to others on statistically valid sampling plans for inspection and acceptance criteria
  
• Serve as technical resource for process improvements projects such as alternative measurement/testing methodologies, and supplier supplied data, and Master Lot qualification programs.
  
• Problem solving through classical & experimental design methods
  
• Assists Incoming Quality in resolving internal and external audit findings and observations, non-conformance reports, and corrective actions as needed.
  
• Provide hands-on technical support for Receiving Inspection personnel as required.
  
• Develop procedures for the purpose of improving IQA and supplier support processes.
  
• Responsible for assisting in the development of inspection methods for new materials, components, and sub-assemblies
  
• Review and improve sampling plans for new or existing materials and components.
  
• Review incoming material and/or in-process rejections and determine appropriate corrective actions.
  
• Serve as part of auditing teams and as lead auditor for Supplier Quality, as required.
  
• Follow-up responsibility for Supplier Corrective Actions.
  
• Assist in the qualification, selection, and development of new suppliers as needed.
  
• Member of new product development teams.
  
• Occasional extensive travel to suppliers as required.
  
• Performs responsibilities required by the Quality System and other duties as assigned or requested.
  
  Education and Experience:
  Bachelor's degree in Mechanical Engineer or Polymer Engineer with extrusion experience preferred. 5-8 yeras in medical device or similar industry. Knowlede and understanding of related quality standards including ISO, GMPs, and ASTM. Demonstrates key knowledge of specialized disciplines (experience in principals of mechanical, metallurgical, electrical, etc) which significantly contributes to material quality programs. Knowledge of statistical sampling as well as the ability to interpret techncail drawings and geometric tolerances and dimensions is required. Knowledge and experience in process and product validation a must.
  
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