Summary
Overview
Work History
Education
Skills
Certification
Awards
Timeline
Generic

Mahsa Karimi

Toronto,Ontario

Summary

Personable Biotechnology Engineer with critical thinking and dynamic communication skills. Well-versed in various cell therapy projects and enjoys researching topics.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Research Assistant

University of Toronto
Toronto, ON
09.2020 - Current
  • Dealt research on the development of a microfluidic device and biomimetic hydrogel such as collagen and therapeutic cells scaffold for regenerative medicine, with a focus on wound healing
  • Prepared comprehensive reports summarizing research findings.
  • Managed in the design and implementation of experimental protocols in laboratory experiments to confirm research hypotheses.
  • Verified accuracy of data by conducting quality assurance checks on collected materials.
  • Collaborated with other researchers in developing study designs, methods, and tools for data collection.
  • Composed technical documents such as journal articles, conference presentations, posters, and book chapters related to ongoing research initiatives.
  • Utilized knowledge of scientific principles and techniques to troubleshoot problems encountered during the course of research.
  • Conducted qualitative and quantitative analysis on assigned data.
  • Participated in extra training and courses to refine and improve upon industry knowledge.

Biomedical Engineer

Thechnomed
Richmondhill, BC
02.2020 - 04.2021
  • Prepared audit reports and provided recommendations for process improvements to ensure compliance with corporate policies
  • Reviewed and tested biomedical equipment for accuracy, reliability, and compatibility with other components.
  • Evaluated existing products for compliance with industry regulations and standards.
  • Implemented quality assurance protocols to ensure that all products met required specifications.
  • Adhered to all laboratory guidelines and regulations to verify safety and protective procedures.

ADVISORY CONSULTANT

Agah Afarin Aria
06.2018 - 01.2020
  • Provided expert advisory services to manufacturers in developing and executing efficient medical device quality management systems in compliance with local government regulations and related product certification requirements
  • Analyzed data and identified trends in order to develop actionable insights.
  • Drafted reports, presentations, and other materials for senior management review.
  • Evaluated current processes and systems for areas of improvement or optimization.
  • Identified potential risks associated with proposed changes or strategies.
  • Collaborated with cross-functional teams to implement new processes or procedures.
  • Prepared accurate and concise reports, conveying progress, issues and solutions.
  • Identified risks and assessed potential impact, consulting with clients to prepare mitigation plan.
  • Documented research findings and prepared polished reports highlighting results and potential improvement strategies.
  • Devised new and improved records management programs to organize and protect data.

MEDICAL DEVICE AUDITOR

Agah Afarin Aria
07.2017 - 01.2020
  • Participated in the ISO 13485:2016, ISO 9001:2015, and CE Certificate Issuance process for Medical Device Standardization and Directives
  • Conducted on-site audits to assess compliance with ISO standards and regulations.
  • Developed audit plans, identified deficiencies, and recommended corrective action for non-conformance.
  • Documented audit results, findings and recommendations in concise reports.
  • Verified implementation of corrective actions taken by management to address identified issues.
  • Evaluated internal control systems for effectiveness and efficiency.
  • Reviewed operational processes to ensure conformance with established requirements.
  • Performed risk assessments to identify potential areas of concern or improvement opportunities.
  • Provided guidance and training to personnel on best practices for meeting quality standards.
  • Maintained knowledge of current industry trends, developments, and regulatory changes that may affect operations.
  • Facilitated communication between departments regarding process improvements related to ISO requirements.
  • Ensured compliance with organizational policies and procedures through periodic reviews and audits.

Quality Assurance Specialist

NikMed
Tehran, Tehran
01.2019 - 12.2019
  • Developed and maintained quality assurance protocols, processes and procedures for manufacturing saliva succession catheters.
  • Reviewed customer requirements and specifications to ensure products met ISO 13485 and ISO 9001 standards.
  • Monitored production operations for conformance to established quality standards.
  • Worked closely with suppliers to ensure that components met required specifications.
  • Participated in supplier evaluation activities including audits, assessments, evaluations.
  • Identified areas of improvement within the existing Quality Management System.
  • Ensured compliance with all relevant safety regulations during testing phases.
  • Analyzed quality assurance data to identify trends and develop and implement corrective action plans.
  • Collaborated with management to discuss effective plans for resolving major quality problems.
  • Analyzed data from inspection results for trends in order to recommend process improvements.
  • Performed root cause analysis of defects identified during testing cycles.
  • Verified accuracy of product documentation such as labels, instructions, warnings.
  • Provided feedback on product design changes based on testing results.
  • Created reports summarizing findings from inspections and tests conducted.
  • Investigated customer complaints regarding quality issues and implemented corrective actions accordingly.

MEDICAL DEVICE AUDITOR

Iranian Govah Cosar, IGC
Tehran, Iran
06.2015 - 07.2017
  • Spearheaded Medical Device Standardization & Directive initiatives while participating in ISO 13485 & ISO 9001 Certificate Issuance Processes
  • Conducted on-site audits to assess compliance with ISO standards and regulations.
  • Developed audit plans, identified deficiencies, and recommended corrective action for non-conformance.
  • Documented audit results, findings and recommendations in concise reports.
  • Verified implementation of corrective actions taken by management to address identified issues.
  • Reviewed operational processes to ensure conformance with established requirements.
  • Evaluated internal control systems for effectiveness and efficiency.
  • Performed risk assessments to identify potential areas of concern or improvement opportunities.
  • Maintained knowledge of current industry trends, developments, and regulatory changes that may affect operations.
  • Assessed the effectiveness of management controls over key business functions such as inventory management, accounting procedures, purchasing policies.
  • Collaborated with stakeholders to develop strategies for ensuring compliance with applicable laws and regulations.
  • Interacted regularly with all levels of staff throughout the organization to ensure understanding of ISO standards.
  • Facilitated communication between departments regarding process improvements related to ISO requirements.
  • Investigated customer complaints concerning product quality or service issues.
  • Conducted follow-up audits to verify implementation of corrective actions taken by management teams.
  • Prepared comprehensive summaries detailing the status of audit projects for senior leadership review.
  • Ensured compliance with organizational policies and procedures through periodic reviews and audits.

Education

PH. D IN BIOMATERIALS-BIOMEDICAL ENGINEERING -

University of Toronto
09.2023

MASTER OF SCIENCE (M.S.) IN BIOMATERIAL-BIOMEDICAL ENGINEERING -

University of Tehran
02.2019

BACHELOR OF SCIENCE (B.S.) IN MATERIAL ENGINEERING -

University of Qazvin
09.2015

Skills

  • ImageJ/Fiji
  • Computer and software Personality
  • Microsoft office
  • AutoCAD/Autodesk
  • Fluid simulation software
  • MATLAB
  • Python
  • Experimental Design
  • Technical Writing
  • Compliance standards
  • Regulatory Compliance
  • Quality Assurance
  • Statistical Analysis
  • Quality Assurance Controls
  • Problem solving
  • Management/Leadership
  • Tech-savvy

Certification

  • ISO 13485:2016 lead auditor certificate, Global Exemplar, 04/2022
  • Quality Management System Lead Auditor, ISO 9001:2015 Lead Auditor, CQI, IRCA certified AJA Academy, 03/2017
  • Quality Management System Lead Auditor for medical device, ISO 13485:2016 Lead Auditor, BRS Academy, 01/2017
  • Introduction of Biomedical Device Standards ISO 10993, ISO 11737, and ISO 11607, KiaNanoBioVista Co., 01/2019
  • Medical Device Risk Management requirements ISO 14971:2012, BRS Academy, 05/2017
  • The certified technical officer of Medical Equipment Manufacturers, Iranian Medical Device Society, 10/2016
  • CERTIFICATE OF COMPLETION of Health Science Industry Training modules: Innovation and Commercialization, Project Management, Strategic Business Development, IP & Licensing, QMS & GMP, Biomanufacturing, Finance, Partnerships and Contracts, Market Intelligence, Professional Skills & Business Communications, 08/2023
  • Python, coursera

Awards

Full-time Ph.D. scholarship in material science and engineering, University of Toronto, 09/2020 William C. Wingard Award in Advanced Materials, University of Toronto, 02/2022 F.H Guest bursary award in Material science and engineering department, 2023

Timeline

Research Assistant

University of Toronto
09.2020 - Current

Biomedical Engineer

Thechnomed
02.2020 - 04.2021

Quality Assurance Specialist

NikMed
01.2019 - 12.2019

ADVISORY CONSULTANT

Agah Afarin Aria
06.2018 - 01.2020

MEDICAL DEVICE AUDITOR

Agah Afarin Aria
07.2017 - 01.2020

MEDICAL DEVICE AUDITOR

Iranian Govah Cosar, IGC
06.2015 - 07.2017

PH. D IN BIOMATERIALS-BIOMEDICAL ENGINEERING -

University of Toronto

MASTER OF SCIENCE (M.S.) IN BIOMATERIAL-BIOMEDICAL ENGINEERING -

University of Tehran

BACHELOR OF SCIENCE (B.S.) IN MATERIAL ENGINEERING -

University of Qazvin

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Mahsa Karimi