fady khalla

senior specialist, design controls, risk management and human factors

About

Certified Six Sigma Green Belt Biomedical Engineer with three years of experience in medical device quality engineering and document control. In addition, two years of research experience in microfluidics and cardio vascular engineering. * Outstanding research, and planning expertise, coupled with strong technical writing, and presentation skills. * Robust knowledge of Good Manufacturing Practice (cGMP), and Quality System Regulations (QSR). * Extensive exposure to Food and Drug Administration regulations, procedures, and standards. * Thoroughly trained to implement and audit ISO 13485, ISO 14971, IEC 62304 and EU MDD 93/42/EEC. * Superb communication and organizational skills, with the ability to work independently as well as part of a team * Exceptional attention to detail and proven ability to identify process improvement opportunities * Ability to effectively prioritize workload to meet deadlines and work objectives; uses resources effectively and efficiently; able to organize and self-direct execution of tasks/duties

Country

united states

City

new york

Industry

pharmaceuticals

Skill

medical devices, biomedical engineering, matlab, quality system, fda, iso 13485, capa, software documentation, gmp, quality assurance, root cause analysis, labview, validation, solidworks, research, iso 14971, microscopy, sop, regulatory affairs, six sigma, statistics, autocad, microsoft office, imagej, microfluidics, maple, fmea, u.s. food and drug administration, ares, after effects, indesign, adobe audition, circuit design, printed circuit board manufacturing, 21 cfr part 11, quality auditing, risk analysis, risk management, supplier evaluation, medical device directive, management review, dfss green belt, technical files, inspection, verification, iec 62304, ptc creo, complaint investigations, dmaic, iec 60601

Experience

senior specialist, design controls, risk management and human factors

merck

2018-5 - Present · 8 yrs 5 mos

qa inspector and document control specialist

omnyx

2013-3 - 2013-9 · 7 mos

* Inspect manufacturing parts, and tools before transferring them to manufacturing department. * Validate inspection plans, device history records, device master records, and calibration reports. * Verify, and approve engineering changes implementation reports. * Maintain up-to-date documentation system in CompliancePro (ERP system), complying with ISO 13485.

engineering specialist, design control and risk management

merck

2016-8 - Present · 10 yrs 2 mos

This site is intended only for residents of the United States and its territories. Merck is known as MSD outside the United States and Canada. Today's Merck is a global healthcare leader working to help the world be well. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. Merck. Be well. For more information, visit www.merck.com.

quality engineer

milestone scientific inc.

2013-9 - 2016-8 · 3 yrs

Education

rutgers university

medical engineering

2010-1 - 2014-1 · 4 yrs 1 mo

Awarded Aresty Undergraduate Research Fellowship,June 2012-June 2014 Dean's List, Spring 2011 - Spring 2014 Member of Coptic Orthodox Youth Fellowship. Activities and Societies: Tau Beta Pi Engineers Without Borders

new jersey institute of technology

medical engineering

2015-1 - 2017-1 · 2 yrs 1 mo

Medical Device Development - Systems Management for Medical Devices - Orthopedic Medical Device Design - Biomaterials - Virtual Instrumentation (LabVIEW) - Mechanical Design (Creo/Pro-E)