Senior Quality Engineer - Exton, PA

Responsible for product-related root cause analysis, process mapping and impact assessments for change control. Responsible for product-related root cause analysis, process mapping and impact assessments for change control. Analyze non-conforming materials and returned goods and recommend disposition and corrective actions Create suitable data analysis tables and report findings based on statistical evidence and trending Provide analytical investigations and develop root cause for non-conformances and deviations Conduct statistical analysis and support key customer accounts as Quality Lead Assist in the performance of qualification and validation studies Assist with product development and in the transition of development products and projects Review new product designs (internal and external) and make recommendations for quality requirements Plan, write and implement DOE's and test protocols required to evaluate new and existing products Evaluate, identify and implement QA improvements to existing processes or products Supportive environment where individuals are empowered to progress and contribute to meaningful change. Experience in Biomaterials, Polymers, Chemistry or Biomedical Engineering preferred. Experience in statistical analysis (Minitab, Excel). Experience with ISO 9001, ISO 13485, or 21 CFR820 required. Proficient in MS Office software including Word, Excel, and Outlook.