Razi Uddin
Senior Quality Engineer @Cirtec Medical
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WORK HISTORY
Senior Quality Engineer @Cirtec Medical
Santa Clara, CA, US
Provided Quality Engineering support for engineering product development and sustained manufacturing of catheters.• Ensured quality requirements are communicated and met at suppliers• Reviewed manufacturing records to perform lot release activity for catheters, including COC issuance.• Provided Quality Project Management support as needed for product transfers from development to validation to production.• Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination.
EDUCATION
Ryerson University
Bachelor of Engineering , Chemical Engineering
ABOUT RAZI UDDIN
Professional Statement:• 7+ years’ hands-on technical problem-solving experience in quality engineering with a specialty in design and development, root cause analysis, and sustained manufacturing. Worked on products such as polymers (cast resins/ dental fillers), fluidic systems, vaccines/syringes, pharmaceutical manufacturing equipment, flow cytometers (IVD/RUO), surgical robotic systems, and neuro-vascular/pulmonary catheters.• High level of technical aptitude and ability to understand engineering, design, process, and product performance issues and identify, assess and solve problems with strong attention to detail. • Software: MATLAB, C, SolidWorks, Aspen HYSYS, AutoCAD, Solinist Levellogger, Arduino, Adobe Photoshop, Microsoft Office (Visio, Excel, PowerPoint, Word, Access, MS Project), Tableau, Minitab, LIMS, ELN, LES, AFT Fathom, SAS, AFT Arrow, and QMS• Compliance and Regulatory Standards: OSHA, ASME, ISO Series, ISO ASTM Industrial Chemical Standards, cGMP, ASTM D4169, TAPPI, USP, EP, GLP, HACCP, Supplier Change Control Policies, FDA, 21 CFR, ISO 13485: 2016, ISO 14971, CMDR, QSR, MDD• Characterization: Polymer Physics and Chemistry, Fourier Transform Infrared Spectroscopy (FTIR), Four Point Probe Operation for Conductivity Measurement, Ultraviolet Visible Spectroscopy (UV-Vis), Gel-Permeation Chromatography (GPC), Gas Chromatography with Flame Ionization, X-Ray Powder Diffraction (XRD),Ultrafiltration, Normal Flow Filtration, HPLC, Mass Spectrometry, Gel Scan Densitometry, SDS-PAGE, Absorbance and protein assay, Product titter assay, ELISA, SEM, AFM, FTIR, TGA, DSC, Flow Cytometry Techniques, Cell Cultures, PCR/qPCR, Gel Electrophoresis• Equipment: Calibration Scheduling & Management System, Spray Drying Equipment, Chemical Reactors, Bioreactors Mixing & Blending Systems, Process & Storage Tanks, Filtration Systems, CE-SDS, Western Blot, Milling Machines, and Drill Presses• Certifications: EIT, GMP, Process Control, Six Sigma Green Belt, Advanced Manufacturing Process Analysis, Chemical Processes Principles, Material Processes, Industrial Biotechnology, P & ID, PFD, Dairy, Food Process and Product Technology, ISO Food Safety Management System (FSMS), WHMISI am currently open to opportunities anywhere in the US, especially in California.
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