Senior Medical Device QA Manager

NXTPoint Logistics; Atlanta (GA); On-site; USD 100,000 - 150,000; Full time

Job summary

NXTPoint Logistics is seeking a Medical Device Quality Assurance Manager to lead the site’s quality program, ensuring QMS controls meet FDA 21 CFR 820/QMSR and ISO 13485 where applicable across manufacturing, packing, labeling, storage, and distribution.

The role partners with operations, customers, and cross‑functional teams to ensure product quality, traceability, audit readiness, and CAPA, with duties including training, investigations, deviation handling and ongoing improvement.

Qualifications

• Minimum 5 years of progressive quality experience in medical device, regulated or FDA-regulated environments.
• Experience with FDA 21 CFR Part 820/QMSR and ISO 13485 is highly preferred.
• ASQ certification or ISO 13485 auditor certification is preferred.

Responsibilities

• Lead site quality management system activities for medical device operations, including contract manufacturing, kitting, labeling and distribution.
• Maintain QMS controls aligned with regulatory requirements and customer specifications.
• Serve as primary quality contact for audits, regulatory inquiries and CAPA management.
• Manage investigations, nonconformances, deviations, and risk assessments.
• Develop training programs and ensure staff competency for regulated operations.
• Support audits and inspections, maintain inspection-ready records and traceability.
• Drive continuous improvement through corrective and preventive actions and metrics.

Skills

Quality systems

Regulatory compliance

CAPA investigations

Audit readiness

Cross-functional leadership

Traceability

Documentation control

Education

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

Tools

WMS

Job description

NXTPoint Logistics is seeking a Medical Device Quality Assurance Manager to lead the site’s quality program, ensuring QMS controls meet FDA 21 CFR 820/QMSR and ISO 13485 where applicable across manufacturing, packing, labeling, storage, and distribution.

The role partners with operations, customers, and cross‑functional teams to ensure product quality, traceability, audit readiness, and CAPA, with duties including training, investigations, deviation handling and ongoing improvement.