Medical Device QA Leader — Quality & Compliance

suddath; Duluth (GA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive benefits

401(k) with company match

Weekly pay

Paid Time Off (PTO)

Tuition reimbursement

Job summary

Suddath is seeking a Medical Device Quality Assurance Manager to lead the site quality program supporting contract manufacturing, kitting, packaging, labeling, storage, and distribution. The role ensures QMS controls are compliant with FDA and customer requirements and drives continuous improvement.

The position partners with operations, clients, and cross-functional teams to ensure product quality, traceability, audit readiness, and trained personnel.

Responsibilities

• Lead medical device QMS activities across manufacturing, kitting, packaging, storage, and distribution.
• Ensure work aligns with client specs, instructions, quality plans, and regulatory requirements.
• Maintain QMS controls per FDA 21 CFR Part 820/QMSR and ISO 13485 where applicable.
• Act as site quality contact for client reps, regulators, audits, and CAPA.
• Oversee deviations, nonconformances, CAPA, risk assessments, and corrective actions.
• Support audits, recall preparedness, training, and inspection readiness.

Job description

Suddath is seeking a Medical Device Quality Assurance Manager to lead the site quality program supporting contract manufacturing, kitting, packaging, labeling, storage, and distribution. The role ensures QMS controls are compliant with FDA and customer requirements and drives continuous improvement.

The position partners with operations, clients, and cross-functional teams to ensure product quality, traceability, audit readiness, and trained personnel.