Atec Spine Carlsbad , CA 92008
Posted 2 weeks 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.
Atec Spine