Medical Device Quality & Compliance Lead

NXTPoint Logistics; Duluth (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

NXTPoint Logistics seeks a QA Manager to lead the medical device quality program across contract manufacturing, kitting, packaging, labeling, and distribution. You will maintain the site’s QMS in line with FDA 21 CFR Part 820/QMSR and ISO 13485, ensuring traceability, audit readiness, and continuous improvement in collaboration with operations and cross-functional teams.

You will oversee CAPA, investigations, nonconformances, training, and inspection readiness while driving metrics and supplier

Qualifications

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related field.
• Minimum 5 years of progressive quality experience in medical device or FDA-regulated environments.
• Experience with FDA 21 CFR Part 820/QMSR, ISO 13485, and audits is strongly preferred.
• ASQ certification or ISO 13485 auditor certification preferred.

Responsibilities

• Lead the facility's medical device Quality Management System activities supporting contract manufacturing, kitting, packaging, labeling, storage, fulfillment, and distribution.
• Maintain operation-specific QMS controls aligned with FDA 21 CFR Part 820/QMSR and ISO 13485 requirements.
• Serve as the site's primary quality contact for client quality reps, regulatory inquiries, audits, and CAPA.
• Manage deviations, nonconformance, CAPA, risk assessment, and corrective actions.
• Prepare for client, certification, and regulatory audits with inspection-ready processes.

Skills

Regulatory compliance

CAPA & complaints handling

Audits

Traceability

Quality systems

Education

Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related field

Tools

WMS systems

Job description

NXTPoint Logistics seeks a QA Manager to lead the medical device quality program across contract manufacturing, kitting, packaging, labeling, and distribution. You will maintain the site’s QMS in line with FDA 21 CFR Part 820/QMSR and ISO 13485, ensuring traceability, audit readiness, and continuous improvement in collaboration with operations and cross-functional teams.

You will oversee CAPA, investigations, nonconformances, training, and inspection readiness while driving metrics and supplier