Job experience

• March 2022 - present
  Quality and Manufacturing Engineer
  GoCheck Kids (Gobiquity, Inc.)
  

  Santa Clarita, CA, USA

  • Developing test protocols for new product version release;
  • Generating test reports;
  • Issuing non-conforming material reports and collaborating with material review board (MRB);
  • Analysis of non-conformances using methods such as Pareto charts, disc charts, etc;
  • Updating and control of finished product and parts inventory;
  • Collaborating with product design/development, software, and sales teams;
  • Verification of manufacturing processes;
  • Participating in development and revision of production procedures;
  • Participating in development of procedure for returned product process;
  • Approving device history records for release of manufactured or refurbished products;
  • Developing methods, including diagrams, for tracking test results;
  • Improving product requirements documents;
  • Interim manufacturing manager position for four months (March, 2023 through June 2023);
  • Performing incoming material inspection and developing inspection documents and reports.
  

• May 2018 - present
  Quality Consultant (Part Time)
  ATECHSO - Avance Tech Solutions, Inc.
  

  Burbank, CA, USA

  • Conducting internal audits of the quality management system;
  • Advising the management on CAPA;
  • Helping with root cause analysis to detect the potential causes of problems associated with the QMS.
  

• April 2017 - February 2022
  Regulatory / Validation Specialist
  PMA Services, Inc.
  

  Norco, CA, USA

  • Performing analytical validation study including carryover, precision, linearity, calibration, quality control, and correlation studies using EP Evaluator software, based on the test results obtained from the laboratories;
  • Maintaining and updating product validation procedures to ensure compliance with regulatory requirements;
  • Documentation; Reviewing product validation documents and records to ensure compliance with regulatory requirements (FDA, CLIA, CAP, COLA);
  • Running proficiency testing on hematology systems and reporting results;
  • Created reagents inventory;
  • Creating and updating consumption graphs used to forecast future consumption and develop and update reorder points.
  

• August 2016 - June 2017
  BMET
  enBio Corp.
  

  Burbank, CA, USA

  • Performing PMs and QC services of medical equipment on clients’ sites.

• June 2016 - August 2016
  Quality Control Inspector
  Regent Aerospace
  

  Santa Clarita, CA, USA
• November 2009 - October 2015
  Quality Control Manager
  Advance Medtronics Co.
  

  Tehran, Iran

  • Managing the quality management system of the company based on ISO 13485 requirements;
  • Evaluating the overall performance of the service department in terms of quality of services delivered to customers;
  • Supervision over documentation/filing system;
  • Defining and evaluation of corrections, corrective actions, and preventive actions (CAPA);
  • Design and establishment of statistical controls for sales and after sales services departments;
  • Customer complaints/satisfaction analysis and keeping in touch with them;
  • Keeping up with new legislations and updating the system when/where required;
  • Reporting directly to the managing director and the general manager.
  

• December 2007 - November 2010
  QC/Service Engineer
  Advance Medtronics Co.
  

  Tehran, Iran

  • Installation, general service, repair, and QC of medical laboratory devices including hematology analyzers, blood gas analyzers, and electrolyte analyzers;
  • Training laboratory staff on operation and user maintenance of the above-mentioned devices.
  

• December 2007 - November 2010
  QMS Auditor (Part Time)
  Moody International Certification (MIC)
  

  Tehran, Iran

  • Conducting QMS audits against ISO 9001 standard as a lead / auditor for mostly automotive, health, and design and production sectors.

Education

• Azad University, Tehran, Iran
  B.S. in Mining Engineering
  

  - present

• ISO 9001 Lead Auditor Certificate
  Moody International Certification (MIC)
  

  - present
• ISO 9001 Internal Audit based on ISO 19011 Standard
  Moody International Certification (MIC)
  

  - present
• QMS Basics, Documentation and Requirements Certificate
  TÜV Academy, Iran-Germany
  

  - present
• ISO/IEC 20000-1 Service Management Systems
  Udemy (online)
  

  - present
• Cal/OSHA Compliance
  PRYOR Learning Solutions
  

  - present
• HIPAA Basics
  Gobiquity Inc.
  

  - present