Sheida Toussi (Toussi Pmp Thomas) Ms

Director of Quality, Regulatory Affairs, and Compliance at Mawi DNA Technologies

A results-oriented and performance-driven operations leader with over fifteen years of experience in organizational leadership, communication & change management, customer acquisition, and in all aspects of the medical device, combination products drugs, and in-vitro diagnostics industries. Close attention to detail, and the ability to effectively solve problems within timelines while working on multiple projects. An influential leader who works with cross-functional teams that consistently delivers improvements in customer satisfaction, quality, and product performance. • Implementation of EU MDR • Post Market Surveillance (PMS/ MDR /Vigilance • Product Complaint Investigation Risk Management • Recalls/ Field Communications • Quality System Regulations (QSR) • Product and Process Development • Customer Acquisition & Change Management • Nonconforming and CAPA• Quality Management Systems (QMS) • Research and Technical Product Development • Customer Support • Technical & GMP Training • Design control • Validation and Verification • Corporate and Regulatory Strategy • Quality and Regulatory Compliance • Internal Audits & Supplier Audits and Inspections • Supplier and Contract Manufacturer