Mandana Lotfazar
Development Quality (Automated Test System and R & d) @Abbott
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WORK HISTORY
Development Quality (Automated Test System and R & d) @Abbott
Manager Design Assurance and Staff Development Engineer -December 2017 to PresentSenior Quality Assurance Engineer - Feb 2014 to Dec 2017Design Assurance Engineer II - Feb 2009 – Feb 2014Design Assurance Engineer I - Aug 2008 – Feb 2009• Held leadership roles in Quality Assurance with the main focus of establishing processes and operating policies to contribute in shortening product development life cycle, training, maximizing efficiency and productivity of the departments (Automated Test Engineering, R&D, Manufacturing and Inspection). Involved with Manufacturers globally (ex: Malaysia, Puerto Rico, Liberty and Scottsdale). Collaborated with various functional teams such as Automated Test System/ Manufacturing Engineering, Electrical/R&D, Mechanical, MRI, Firmware ( Product, RF and BLE) Development, Metrology, Inspection, Fault Isolation, Document Control, Program Management and Quality Operation.• Characterization and Design Verification, data analysis, Verification and Validation of new Product(ICD or Pacemaker) including writing of engineering plans, reports, and specifications. Technical guidance, analytical consultation and issue resolution in collaboration with ATE and (Sylmar and Sunnyvale) R&D groups for all relevant Non-product SW/HW releases since the beginning of the development process to release and even through regulatory (FDA) submission as needed. • Process Validation (IQ, OQ, PPQ), Inspection and Audit activities.
EDUCATION
California State University, Northridge
Second Master of Science (M.S.), Manufacturing System Engineering Management
California State University, Northridge
Master of Science (M.S.), Electrical and Electronics Engineering
Islamic Azad University North Tehran Branch
Bachelor's degree, Computer Science
SKILLS
ABOUT MANDANA LOTFAZAR
Passionate and detailed oriented leader with over fifteen years of experience in the area of Automated Software, Firmware and System Test Engineering (ATE), Non-Product Development (R&D), Verification & Validation (V&V), Quality Assurance/Testing, Manufacturing Process Improvements, Metrology, Inspection and Regulatory Requirements (FDA/ISO/EU) in Aerospace and Medical companies. Expert in all the Medical Device non-product automated and COTS standards. Holds a Master of Science (MS) focused in Electrical Engineering and Manufacturing System focused on engineering management skills from California State University of Northridge. I maintain up-to-date skills by acquiring and maintaining key Professional Certifications from Quality organizations such as AAMI and ASQ. Solutions-oriented leader, mentor, and manager experienced in over-seeing the Quality and Regulatory Compliance activities with focuses on optimum Quality Systems and process improvements. Six-time Quality Sleute, silver award recipient, award given to outstanding contributor(s) of the CRM Quality and Manufacturing system improvement.Knowledge on regulation/ Standards: 21 CFR 820, 803, 806, Part 11, FDA Design Controls, ISO 13485, ISO 14971, IEC 62304, IEC ISO9001/ISO13485, GMP/QSR, Risk Assessment, Cyber security/Data Integrity, and DO-178B
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