Quality Analyst

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

Job Title: Quality Analyst (Medical Devices)

Duration: 1+ year contract

Responsibilities

• Lead timely investigations of product and process nonconformance events; collect evidence, interview stakeholders, and document findings to create clear, complete NCRs.
• Perform root cause analysis using structured tools (5 Whys, fishbone, Pareto) and recommend containment, correction, and corrective/preventive actions in partnership with Quality and Operations.
• Prepare concise, audit-ready reports; maintain accurate records within the Quality Management System (QMS) to ensure traceability and data integrity.
• Monitor trends and metrics, support risk assessments, and contribute to continuous improvement initiatives using Lean and Six Sigma principles.
• Support Quality Inspection, as needed
• The list of duties and responsibilities is not exhaustive and may include and/or be substituted as necessary with other tasks as defined by management.

Education

• Bachelor’s degree in engineering, life sciences, quality, or a related field; or equivalent practical experience.

Experience

• 3+ years in manufacturing or quality, preferably in a medical device or other regulated environment.

Preferred qualifications

• Working knowledge of ISO standards relevant to medical devices (e.g., ISO 13485), 21 CFR 820, Good Manufacturing Practice (GMP), and Total Quality Management (TQM).
• Hands-on experience with Corrective and Preventive Action (CAPA), nonconformance workflows, and electronic QMS platforms.
• Six Sigma Green Belt or equivalent; proficiency with data analysis tools such as Excel or Minitab.