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ATEC Spine · 18 hours ago

Supplier Quality Engineer II

Carlsbad, California, United States

Full-time

Onsite

Mid Level

ATEC Spine is focused on spinal orthopedic implants and instruments, and they are seeking a Supplier Quality Engineer II to oversee supplier quality activities. The role involves managing supplier performance, conducting audits, and ensuring compliance with quality standards and regulations.

Health CareMedical DeviceProduct Design

H1B Sponsor Likely

Responsibilities

Manage supplier quality activities, including performance monitoring, issue resolution, and continuous improvement initiatives

Build and maintain effective working relationships with assigned suppliers, serving as a quality point of contact and supporting on-site supplier visits, audits, and periodic business or quality reviews

Support supplier selection, approval, classification, and development through a combination of audits and product or process qualifications

Conduct on-site audits and supplier performance evaluations based on company procedures and ensures compliance with the supplier’s management system

Provides input into supplier audit schedules and ensure completion of audits per audit schedule

Utilize risk management methodologies to influence risk-based decisions tied to supplier qualification, supplier change requests, and nonconforming product

Support maintenance of the Approved Supplier List

Represent supplier quality engineering in technical teams, setting priorities for corrective action efforts and leading related failure investigations as required

Manage supplier change requests, ensuring cross-functional review, risk assessment, and compliance with internal change control and regulatory requirements

Support second sourcing initiatives by assisting with supplier qualification activities, risk assessments, and documentation to ensure alternate suppliers meet quality and regulatory requirements

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

Coordinate Manufacturer Qualification activities including but not limited to Part Qualifications, Gage R&R, correlation studies and process development

Perform customer complaint investigations on products manufactured by suppliers

Analyze supplier quality data and provide results for Management Review

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

Participate in FDA, MDSAP, ISO and other regulatory audits

Traveling is approximately 10-30% as required

Other duties as assigned

Qualification

Supplier Quality ManagementAuditingRisk ManagementStatistical AnalysisRegulatory ComplianceContinuous ImprovementSupplier Relationship ManagementCross-functional Collaboration

Required

Responsible for executing supplier quality activities and supporting the quality performance of external product and service suppliers used in spinal orthopedic implants, instruments, software, and capital equipment

Focuses on developing and maintaining supplier capability through audits, corrective actions, change management, and continuous improvement initiatives

Works cross-functionally with Supply Chain, R&D, Regulatory, Quality, and Operations to support new product development and sustaining activities

Manage supplier quality activities, including performance monitoring, issue resolution, and continuous improvement initiatives

Support supplier selection, approval, classification, and development through a combination of audits and product or process qualifications

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