Mohsen Sarraf

Personal email: sarrafm@hotmail.com -Provide QE support for product development. Maintain and continually improve the effectiveness of quality system to satisfy the requirements of FDA Quality Systems Regulation (QSR), ISO 13485, ISO 9001. -Develop, maintain, communicate quality metrics for Install Defects, Non-Conforming material, MRB cycle time. Lead and participate in MRB meetings -Develop and maintain internal audit program, including planning and performing audit activities, ensuring timely performance of scheduled audits, and issuance of reports and findings. -Generate risk and hazard analysis using tools such as DFMEA/PFMEA. -Monitor in-house and field non-conformances for trends. Prioritize, assign actions, and monitor execution to plan and effectiveness of part improvement programs. -Actively participate in project teams to ensure implementation of quality processes and guidelines. (21CFR Part 820) -Review complaint documents and generate reports and graphs for management review. -Perform failure analysis on field return products, and drive corrective/preventive actions. -Contribute to the development of failure investigation methods, tools, testing, and generation of test reports. -Review incoming material and in-process rejections, determine appropriate actions and follow through to completion. (CAPA process) -Generate IQ, OQ and PQ documentation, validation & verification on various processes and products. Review of documents such as validation protocols and test reports (CR approval). -Monitor production yield, analyze and take appropriate action. Provide monthly CAPA feeder report and present the data to management.