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Resume Title:Saqib Alavi
Desired Job Title:Quality Engineer / Regulatory Affairs
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.
PROFESSIONAL WORK EXPERIENCE
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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Contact Information: Saqib Alavi