Quality Analyst – Medical Devices, CAPA & Six Sigma

The Judge Group; Greenville (SC); On-site; USD 55,000 - 83,000; Full time

Job summary

The Judge Group is seeking a Quality Analyst to support medical device manufacturing under a 1+ year contract. You will lead investigations of nonconformances, perform root cause analyses, and recommend corrective actions in collaboration with Quality and Operations.

Candidates should have a Bachelor’s in a related field and 3+ years in quality/regulatory settings, with ISO 13485, 21 CFR 820, GMP familiarity, and experience with CAPA and QMS tooling. On-site work in Greenville, SC is expected.

Qualifications

• Bachelor’s degree in engineering, life sciences, quality, or related field, or equivalent practical experience.
• 3+ years in manufacturing or quality, preferably in medical devices or regulated environments.
• Experience with CAPA processes and nonconformance workflows; working knowledge of QMS.

Responsibilities

• Lead timely investigations of product and process nonconformance events and document findings.
• Perform root cause analysis and recommend containment and corrective actions with QA and Operations.
• Prepare audit-ready reports and maintain records in the QMS for traceability.
• Monitor trends, support risk assessments, and contribute to continuous improvement using Lean/Six Sigma.
• Support Quality Inspection as needed.

Skills

Root cause analysis

CAPA

Data analysis

5 Whys

Fishbone diagram

Pareto analysis

QMS documentation

Lean Six Sigma

Education

Bachelor’s degree in engineering, life sciences, quality, or related field

Tools

Excel

Minitab

Job description

The Judge Group is seeking a Quality Analyst to support medical device manufacturing under a 1+ year contract. You will lead investigations of nonconformances, perform root cause analyses, and recommend corrective actions in collaboration with Quality and Operations.

Candidates should have a Bachelor’s in a related field and 3+ years in quality/regulatory settings, with ISO 13485, 21 CFR 820, GMP familiarity, and experience with CAPA and QMS tooling. On-site work in Greenville, SC is expected.