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Resume Details

Resume Title:Saqib Alavi

Desired Job Title:Quality Engineer / Regulatory Affairs

Resume Description:


Saqib Alavi

Seeking opportunity in the medical device industry to grow into challenging levels of corporate opportunity.


·       MS in Biomedical Engineering specializing in QA & Bio-Instrumentation, Lean Six Sigma Green Belt Certified.

·       Working knowledge with US FDA current Good Manufacturing Practices(cGMP’s), ISO 13485, ISO 9001, ISO 14971, documentation procedures for CAPA investigations, driving resolution of Supplier Corrective Action Requests.

·       510k submissions 21 CFR 820 guidelines on Validation, Design, Risk Management

·       Documentation of VMP, executing validations and ensuring issues with NCMR’s or process deviations have been resolved.

·       Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis and process mapping. 

·       Software skills- MATLAB, SolidWorks, Minitab, SAS, MS Word, Excel and PowerPoint Visual Basic.


Biomedical Engineer, Omega Hospital                                                                                                          August 2015-July 2016

·       Performed preventive maintenance inspection, electrical safety testing and corrected problems encountered in Class 2 Class 3 medical devices, accomplishing Standard Operating Procedure.  

·       Evaluated QSR along with safety, efficiency of Biomedical Equipment within the hospital’s responsibility.

·       Significantly involved in inspections by regulatory agencies performing clinical audits as needed.

·       Maintained product quality and integrity through evaluation and disposition of non-conforming materials.

Operations Co-op Engineer, Stellar Meditech                                                                                           January 2015-July 2015

·       Applied problem-solving tools such as fishbone, Pareto, 5-Why's, 8D, Process and Test Method Validation.

·       Assisted in performing Root Cause Analysis to identify effective Corrective actions CAPA and process improvement.

·       Implemented Lean Six Sigma tools including DMAIC, 5s, Kaizen, SIPOC, Value stream mapping minimizing Delays, Cost of Delays, overproduction, unutilized talent and errors.

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