Quality Data Analyst / Quality Systems Specialist

Role:-Quality Data Analyst / Quality Systems Specialist Duration: W2 Contract Job Summary:- We are seeking a Quality Data Analyst to support Quality and Manufacturing teams by analyzing nonconformance events (NCEs), scrap trends, and quality performance data. The ideal candidate will identify systemic issues, assess quality risks, and provide data-driven recommendations to improve manufacturing processes and product quality. Key Responsibilities • Analyze and trend Nonconformance Events (NCEs), scrap data, and quality metrics. • Identify recurring quality issues, process deviations, and systemic trends. • Support CAPA, investigation, and Health Hazard Evaluation (HHE) assessments based on risk and severity. • Create reports, dashboards, and presentations to communicate quality performance. • Develop and maintain Statistical Process Control (SPC) tools, including control charts and process capability studies. • Collaborate with Quality, Manufacturing, and Engineering teams on continuous improvement initiatives. • Monitor manufacturing performance and recommend corrective actions. • Ensure compliance with quality system requirements and regulatory standards. Required Qualifications • Bachelor's degree in Engineering, Quality, Manufacturing, Statistics, or a related field. • Experience in quality systems, manufacturing, or quality engineering environments. • Knowledge of CAPA, Nonconformance Management, Root Cause Analysis, and Quality Investigations. • Experience with SPC, statistical analysis, and data trending. • Proficiency in Excel and data visualization/reporting tools. • Strong analytical, problem-solving, and communication skills. Preferred Qualifications • Experience in Medical Device, Pharmaceutical, or FDA-regulated manufacturing environments. • Familiarity with Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820, or GMP requirements. • Experience with Minitab, JMP, Power BI, Tableau, or similar analytical tools.