Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications. 
• Reviews and analyzes quality trends with the manufacturing team. 
• Considering the quality trends provides directions in terms of setting work priorities for process enhancement. 
• Provides leadership to effective in-depth investigations and to cross-functional, multilevel technical teams to assure causes of non-conformance are identified and understood, and that sound corrective/ preventive actions are implemented. 
• Evaluates the implemented corrective and preventive actions against trends and quality issues to assess effectiveness of it. 
• Leads investigation of customer complaints in alignment with the manufacturing engineers, and process supervisors, facilitates the implementation process. 
• Analyzes data based on trends, recommends actions for process, equipment and system improvement. 
• Writes procedures, protocols and any other documentation needed for the enhancement of systems. 
• Provides training and education to the manufacturing team on tools for process, monitoring enhancement, procedures and equipment, analytical trouble-shooting, FMEA, statistical concept application, and QSR/ISO requirements. Drives implementation of these tools. 
• Analyzes problems regarding inspection procedures, reaches decisions and recommends possible solutions and improvements to implement corrective and preventive actions. 
• Initiates, reports, and recommends special studies and qualification of new products or processes to evaluate quality and reliability. 
• Analyzes and submits recommendations for facilities, environmental areas, such as particulates, humidity, calibrations, and other monitoring. 
• Drives SPC or preventive action methods. 
• Reviews and approves qualification / validation reports, ECO’s/CA’s, process changes, quality records or manufacturing documentation. 
• Implements quality system improvements. 
• Conducts and assists in regulatory inspections, such as (TÜV, FDA, others), as well as internal audits. 
• Integrates Quality Systems Regulations into New Product & Technology Development. 
 Performs other position duties as assigned.