Job Title: Quality Analyst (Medical Devices)
Location: Greenville, SC
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.

Minimum Requirements
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.

Quality Analyst

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