Supplier Quality Engineer
X-spine Systems, Inc. - Miamisburg, OH

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Supply Chain Management

Overall support supplier quality management programs, including more substantive hands-on problem solving and continuous improvement initiatives to raise performance/productivity with suppliers and supply chain.

Own, maintain and report on corporate Supplier Ratings process for strategic suppliers. Refine and maintain X-spine Supplier Survey documentation.

Work with internal customers (i.e., Engineering, Sales, Regulatory, and Fulfillment) to ensure effective problem resolution relating to supplier product/services. Define and establish X-spine Supplier Change Request (SCR) process. Evaluate and determine internal requirements for approval of all specific SCRs and facilitate the flow of required activities.

Lead and maintain Supplier Audit Process, working with the Regulatory Department. Manage all audit and non-conforming product corrective actions (i.e. SCAR).

Coordinate and own the Approved Supplier List/process, including audit for non-compliance/renewals and revisions as required.

Coordinate Supplier Quality Agreement Process in conjunction with Legal and Regulatory as required. Work with critical suppliers to develop relevant Control Plans, PFMEAs, Work Instructions and Acceptance Standards.

Supply Chain Development

Support vendor selection/advanced surveillance/ risk assessment. Ensure that suppliers’ manufacturing and quality systems, special processes and products meet purchase contract requirements and applicable regulatory and government regulations.

Work with Engineering to develop proper key characteristics on drawings.

Coordinate First Article inspection and qualification activities, including more on-site assessment of supplier production process and controls if necessary.

Other duties as assigned by management

Applicant Experience Requirement

Medical Device (ISO 13485) or APQP experience

College Degree or Equivalent Work Experiences

Geometric Tolerancing and Dimensioning. Working knowledge of Metrology

Strong office, verbal communication, written communication, and statistical analysis abilities

About this company
X-spine is a next-generation spinal implant company delivering intuitive technologies for the treatment of spinal disease worldwide....