Medical Device Quality Assurance Leader

The Suddath Companies; Duluth (GA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

The Suddath Companies is seeking a Quality Assurance Manager to lead the site quality program for medical device operations, including contract manufacturing, kitting, packaging, and distribution. You will ensure FDA 21 CFR Part 820/QMSR and ISO 13485 alignment, investigations, CAPA, and audit readiness while partnering across functions.

Strong regulatory knowledge, leadership, and a track record in continuous improvement are essential for success in this role.

Qualifications

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related field.
• Minimum 5 years of progressive quality experience in medical devices or FDA-regulated environments.
• Site quality leadership experience in warehouse, fulfillment, kitting, packaging, labeling, or contract manufacturing preferred.
• ASQ certification or ISO 13485 auditor credentials preferred.

Responsibilities

• Lead site QMS activities for medical device operations and distribution.
• Oversee CAPA, nonconformance, investigations, and disposition activities.
• Coordinate audits, regulatory inquiries, inspections, and customer audits.
• Develop metrics, drive continuous improvement, and ensure regulatory readiness.

Skills

Regulatory compliance

Audit readiness

CAPA

Traceability

Quality systems

Education

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

Tools

WMS

Regulated software

Job description

The Suddath Companies is seeking a Quality Assurance Manager to lead the site quality program for medical device operations, including contract manufacturing, kitting, packaging, and distribution. You will ensure FDA 21 CFR Part 820/QMSR and ISO 13485 alignment, investigations, CAPA, and audit readiness while partnering across functions.

Strong regulatory knowledge, leadership, and a track record in continuous improvement are essential for success in this role.