Medical Device QA Manager — Compliance & Improvement Leader

The Suddath Companies; Duluth (MN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) plan with company matching

Weekly pay for hourly-paid employees

PTO and paid holidays

Tuition reimbursement

Job summary

The Suddath Companies is seeking a Quality Assurance Manager for Medical Devices in Duluth, GA. This role leads the site quality program across contract manufacturing, kitting, packaging, labeling, storage, fulfillment, and distribution, ensuring QMS compliance with FDA 21 CFR Part 820/QMSR and ISO 13485 where applicable.

The ideal candidate will oversee CAPA, nonconformance, investigations, recalls, and audits, and drive continuous improvement while partnering with operations and

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.
• Site quality leadership experience in warehouse/ contract manufacturing preferred.
• Experience with FDA 21 CFR Part 820/QMSR and ISO 13485 preferred.
• ASQ certification or ISO 13485 auditor preferred.

Responsibilities

• Lead the facility's medical device QMS activities across manufacturing, kitting, packaging, labeling, storage, fulfillment, and distribution operations.
• Maintain operation-specific QMS controls aligned with FDA 21 CFR Part 820/QMSR, ISO 13485 where applicable, and customer requirements.
• 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 for compliant, traceable 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 procedures and customer requirements.
• Identify nonconformances, quality risks, regulatory concerns, and process gaps; ensure escalation, investigation, corrective action, and preventive action.
• 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 with required records and traceability.
• Ensure personnel are trained and qualified for medical device operations and maintain training documentation.
• Support risk assessments, validation, revalidation, and maintenance of validated systems, equipment, processes, and quality controls.
• Maintain calibration, qualification, maintenance, environmental monitoring, and storage control records.
• Prepare for and support client, certification, and regulatory audits/inspections.
• Develop and monitor quality metrics, evaluate trends, and drive continuous improvement.

Skills

Quality management

Regulatory compliance

Quality systems

Audits

Cross-functional leadership

Education

Bachelor’s degree in Quality/Engineering/Regulatory affairs

Job description

The Suddath Companies is seeking a Quality Assurance Manager for Medical Devices in Duluth, GA. This role leads the site quality program across contract manufacturing, kitting, packaging, labeling, storage, fulfillment, and distribution, ensuring QMS compliance with FDA 21 CFR Part 820/QMSR and ISO 13485 where applicable.

The ideal candidate will oversee CAPA, nonconformance, investigations, recalls, and audits, and drive continuous improvement while partnering with operations and