Sr. Supplier Quality Engineer

Atec Spine Carlsbad , CA 92008

Posted 4 days ago

The Senior Supplier Quality Engineer is responsible for developing suppliers to provide products and services to ATEC. Works cross-functionally in the development and or maintenance of products and services. The Supplier Quality Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validations as well as statistical analysis and metrics to analyze those systems and processes being measured.

Essential Duties and Responsibilities

  • Leads teams and manage product focus groups working with in-house and suppliers.

  • Conducts on-site audits and supplier performance evaluations based on company procedures and ensures compliance with the supplier's management system.

  • Responsibilities also include being lead supplier quality engineer representative in technical teams, setting priorities for corrective action efforts and leading related failure investigations as required.

  • Liaison between supplier and company for quality related concerns or issues.

  • Provide guidance to suppliers on Alphatec's quality requirements for sustaining and new product development projects (First Article, PFMEA, control plans, and other tools to ensure conformance of product being received).

  • Support New Product Development.

  • Responsible for supporting Development/Operations Engineering and manufacturing to resolve technical issues and implement corrective and preventive actions.

  • Lead supplier development project/activities.

  • Coordinate Manufacturer Qualification activities including but not limited to PQ's, GRR, correlation studies and process development.

  • Manages SCAR process from beginning to end, implementing and follow-up of corrective and preventive actions.

  • Trains quality control associates to ensure inspection procedures and processes are followed and accurate. Develop inspection methods and gauges to improve receiving inspection process.

  • Provide statistical support to suppliers allowing both to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.

  • Perform customer complaint investigations on products manufactured by suppliers.

  • Participate in FDA, ISO and other regulatory audits.

  • Traveling is approximately 10-50% as required.

  • Other duties as assigned.

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