Regulatory and Quality Assurance Director with over 20 years experience in the medical device and pharmaceutical industries. Covered several positions from an engineering position in product development, manufacturing to a director of the Quality Assurance. Experience improving Quality Systems to increase efficiency and meet or exceed the requirements of the FDA and the European Directive.

Director, Regulatory Affairs and Quality Assurance @ From September 2015 to Present (4 months) Director, Regulatory and Quality @ Managing the Regulatory and Quality Assurance departments. Maintaining compliance with the FDA Part 820, ISO 9001: ISO 13485 and the European Directive and other quality standards. Preparing Essential Requirements, Declaration of conformity and Technical files for EU submissions. Working with several distributors around the world to obtain license from their regulatory agencies for export AdvanDx products. Built the Quality Management System at AdvanDx and achieved a certification to ISO 13485 and ISO 9001. Worked on the selection of a paperless product life cycle management application to help manage AdavnDx product development and Quality System. Managing the complaints system to ensure compliance and customer satisfaction, CAPA, the internal audits, suppliers audits. Performing all training, including cGMP. Ensuring compliance with the design control regulations.Reviewing and approving product development phase reports, test protocols, and reports. Managing DCNs activities, and products transfer to manufacturing. Communicating with several contract manufacturers on the validation activities of components and to ensure a smooth product transfer to manufacturing. From October 2006 to September 2015 (9 years) Quality Assurance Manager @ Managed the Quality Assurance department, included a group of 1 quality engineer 1 inspection supervisor and other inspection personnel. Maintained compliance with Quality System as defined by 21 CFR Part 820, ISO 9001: ISO 13485, MDD, AIMD Directive 90/385/EEC and other quality standards. Interface with notified body to maintain annual ISO 13485-facility registration during the audit. Managed QA eventsCAPA, complaints, internal, suppliers audits. Performed training, including cGMP. Reviewed and approved test protocols, test reports, ECNs, and other quality documents. From February 2005 to October 2006 (1 year 9 months) Quality Assurance Manager @ Provide the leadership and management for the development, product transfer and manufacture of medical devices in an FDA QSR, ISO 13485 regulated facility. Monitor and ensure appropriate reporting, review trending, investigate, and analyze failure of complaints. Generated new Design Control policies and procedures. Assist in the development and review and approve validation protocols and reports. Manage internal an external audits including supplier selection and certifications. Lead the development and validation of CAPA Database and managed the efficacy of corrective actions related to device complaints. From April 2004 to April 2005 (1 year 1 month) Quality Assurance Manager @ Managed the Quality Assurance department, included a group of 17 quality personnel. Duties included activities concerned with the maintenance, improvement, compliance and implementation of the Quality System as defined by 21 CFR Part 820, ISO 9001: ISO 13485 and other quality standards. Maintain annual ISO 13485-facility registration during the certifying body audit. Managed internal, suppliers audits, as well as suppliers interface and site audits. Managed and performed various training, including cGMP. Reviewed and approved test protocols, test reports, DCOs, and validation protocols through new products transfer. Communicate developments identified during quality assurance activities and provide recommended corrective actions to senior management during the management reviews. From 2003 to 2004 (1 year) Sr. Quality System Specialist @ Duties included design, preparation, implementation and management of quality systems, including document control and change control; review of existing systems, document review, training, general consulting and auditing for cGMP compliance. Validation of computerized systems, manufacturing facilities and process equipment; preparation and/or review of requirements specifications and qualification protocols; preparation and/or review of standard operating procedures (SOPs); on-site protocol execution; data analysis; and preparation and review of final reports. Perform day-to-day management of assigned projects, project scheduling, tracking, and resource management, as well as client interface, and supply recommendations for corrective actions. From 1999 to 2003 (4 years) Manufacturing Development/Material Engineer @ Product/Process validations of several product lines of innovative devices including defibrillators, patient monitors, etc. Developing, coordinating, testing, analyzing, reporting and implementing hardware and software equipment validations. Investigate and resolve materials issues by determining root cause and implementing corrective and preventive actions for nonconforming products. Work with Incoming Inspection, Manufacturing and Suppliers to implement improvements resulting in reduced costs and cycle time. Propose to management cost summary to fabricate component, products outside the company. Preparing ECN to update drawings, bill of materials and procedures. From February 1998 to March 1999 (1 year 2 months) Sr. Manufacturing Engineer @ Worked on several products transfer to manufacturing, including process validations. Designing and developing custom made machines, instruments and fixtures utilized during manufacturing. Developed processes, specifications and documentation for proper transfer to manufacturing. Coordinating activities with RD, initiating testing, analyzing, reporting and implementing hardware and software equipment validations. Prepared manufacturing and inspections procedures for operators. Investigate and resolve materials issues by determining root cause and implementing corrective and preventive actions for nonconforming products. Reviewed and assessed manufacturing processes and implemented improvements resulting in reduced defects, costs and cycle time. Worked with contract manufacturers on fabrication of products and components to reduce cost and meet time line. Preparing change controls to update documentation, materials and procedures. From 1996 to 1998 (2 years) Development Engineer @ From 1990 to 1996 (6 years)

Master's degree, Mechanical Engineering @ Tufts University From 2011 to 2013 Master's degree, Engineering Management @ Tufts University From 2000 to 2002 Graduate Certificate in Manufacturing Engineering, Manufacturing Engineering @ Tufts University From 1993 to 1993 MET, Mechanical Engineering @ Wentworth Institute of Technology From 1986 to 1990 Emad Lababidi is skilled in: CAPA, FDA, Quality System, ISO 13485, Validation, GMP, Medical Devices, Quality Assurance, 21 CFR, ISO 14971, Design Control, Manufacturing, V&V, ISO, Quality Control