Quality Assurance Manager - Medical Device

NXTPoint Logistics provides a complete range of end-to-end supply chain solutions spanning from distribution, warehousing and fulfillment to managed logistics, transportation and final mile delivery. It leverages broad 3PL capabilities, market-leading technology and deep vertical industry expertise to help both large and small clients reach greater levels of efficiency, service and profitability. With over 30 owned facilities, more than 3.5 million square feet of warehouse space and an extensive partner network, NXTPoint Logistics offers the broad capabilities and reach of a large 3PL company while maintaining its commitment to being the most flexible and responsive provider in the industry.

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The Medical Device Quality Assurance Manager leads the assigned facility’s quality program supporting medical device contract manufacturing, kitting, packaging, labeling, storage, fulfillment, distribution, and related operations. This role is responsible for maintaining site-level Quality Management System (QMS) controls in compliance with applicable FDA 21 CFR Part 820/QMSR requirements, ISO 13485 where applicable, customer requirements, and internal procedures. The position serves as the site’s primary quality resource, partnering with operations, customers, and cross-functional teams to ensure product quality, traceability, regulatory compliance, audit readiness, and continuous improvement across medical device operations.

The role provides oversight of quality records, investigations, nonconformance and CAPA processes, complaint and recall support, training, and inspection readiness activities to support safe, compliant, and efficient operations.

• Lead the assigned facility’s medical device Quality Management System activities supporting contract manufacturing, kitting, packaging, labeling, storage, fulfillment, returns support where approved, and distribution operations.
• Ensure work is performed in accordance with approved client specifications, work instructions, quality plans, statements of work, quality agreements, and applicable regulatory requirements.
• Maintain operation-specific Quality Management System controls aligned with FDA 21 CFR Part 820/QMSR requirements, ISO 13485 where applicable, customer requirements, and company procedures.
• Serve as the site’s primary quality contact for client quality representatives, regulatory inquiries, audits, inspections, complaint support, CAPA activities, recall support, and inspection readiness efforts.
• Manage and continuously improve medical device quality processes, records, controls, and documentation to support compliant, traceable, and inspection-ready operations.
• Oversee product identification, traceability, labeling, packaging, and recordkeeping controls throughout receipt, production, storage, fulfillment, shipment, and approved returns processes.
• Lead product hold, quarantine, stop-ship, nonconforming product, investigation, escalation, and disposition activities in accordance with approved procedures and customer requirements.
• Identify nonconformances, quality risks, regulatory concerns, and process gaps, and ensure appropriate escalation, investigation, corrective action, and preventive action activities are implemented.
• Manage site-level deviation, nonconformance, CAPA, risk assessment, corrective action, and continuous improvement processes for medical device operations.
• Support complaint investigations, recalls, corrections, removals, field actions, and other quality events by providing required records, traceability information, and operational support.
• Ensure personnel are appropriately trained and qualified for medical device operations, maintain required training documentation,…