Summary
Overview
Work History
Education
Skills
Certification
References
Timeline
Generic

Zakia Mizan

FORT WORTH,TX

Summary

Detail-oriented Biomedical Engineer with experience in quality assurance, CAPA, risk management, and process improvement within FDA-regulated medical device and laboratory environments. Skilled in identifying, resolving, and preventing quality issues, optimizing processes through experimental design, and ensuring compliance with regulatory standards as applied in the medical device industry. Experienced in collaborating across departments to drive product and process excellence.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Biomedical Technician/Engineer

Texas Health Resources HEB Hospital
Bedford, USA
05.2021 - Current
  • Performed root cause investigations for device nonconformances and patient incidents, and implemented CAPA processes to drive corrective actions.
  • Developed and applied process control and monitoring systems for FDA Class I-III medical devices.
  • Supported quality assurance initiatives ensuring compliance with FDA, GMP, and internal policies.
  • Authored documentation including incident reports, preventative maintenance logs, and validation records for audits and inspections.
  • Collaborated with cross-functional teams to streamline device maintenance operations, improving process efficiency, and reducing turnaround time (TAT).
  • Participated in risk management activities, assisting in hazard analysis and mitigation plans.

Lab Quality Control/Assurance Specialist

HealthTrackRx
Denton, USA
07.2020 - 02.2021
  • Applied Lean Six Sigma principles to optimize laboratory workflows, increasing operational efficiency and reducing processing times.
  • Conducted validation, verification, and quality control of lab data to ensure compliance with CLIA, CAP, HIPAA, and ISO 15189 standards.
  • Streamlined data entry processes within Laboratory Information Systems (LIMS/LIS) to improve data integrity and turnaround times.
  • Participated in the implementation of corrective actions to resolve identified quality issues.

Biomedical Technologies Intern (R&D)

University of Texas at Arlington Research Institute (UTARI)
Fort Worth, USA
06.2019 - 06.2020
  • Designed and executed experiments for smart medical device prototypes according to FDA design control processes.
  • Developed technical documentation including SOPs, testing protocols, device master records (DMRs), and device history records (DHRs).
  • Supported prototype fabrication using CAD modeling and advanced molding techniques (compression, injection, rotational).
  • Conducted performance testing and validation activities for device optimization and qualification.

Research Assistant (R&D)

University of Texas at Arlington
Arlington, USA
08.2017 - 08.2019
  • Assisted in the design and execution of pre-clinical studies for Class III bioelectronic devices targeting cardiovascular applications.
  • Applied sound problem-solving methodologies to troubleshoot experimental deviations and optimize data acquisition processes.
  • Supported product verification and validation (V&V) activities, including protocol development and test execution.
  • Participated in hazard analysis and contributed to risk assessment documentation for new device concepts.

Education

Bachelor of Science - Computer Science

Southern New Hampshire University
Manchester, NH
01.2024

Bachelor of Science - Biomedical Engineering

University of Texas at Arlington
Arlington, TX
05.2019

Skills

  • Corrective and Preventive Action (CAPA)
  • Root Cause Analysis (RCA)
  • Risk Analysis (FMEA)
  • Process Control
  • Process Monitoring
  • CTQ Management
  • FDA Regulations (21 CFR Part 820)
  • ISO 9001
  • ISO 13485
  • Quality Management Systems (QMS)
  • Environmental Management Systems (EMS)
  • Lean Six Sigma Methodology
  • Agile
  • Scrum
  • Experiment Design (DOE)
  • Data Analysis
  • 3D CAD Design (SOLIDWORKS)
  • FEA (COMSOL, ANSYS)
  • Python
  • Java
  • C
  • C
  • Technical documentation
  • SOPs
  • Protocols
  • DMR
  • DHR

Certification

  • Lean Six Sigma Green Belt
  • HIPAA, CAP, CLIA Compliance Training
  • OSHA, HazCom, and General Laboratory Safety
  • ITIL 4 Foundation

References

References available upon request.

Timeline

Biomedical Technician/Engineer

Texas Health Resources HEB Hospital
05.2021 - Current

Lab Quality Control/Assurance Specialist

HealthTrackRx
07.2020 - 02.2021

Biomedical Technologies Intern (R&D)

University of Texas at Arlington Research Institute (UTARI)
06.2019 - 06.2020

Research Assistant (R&D)

University of Texas at Arlington
08.2017 - 08.2019

Bachelor of Science - Computer Science

Southern New Hampshire University

Bachelor of Science - Biomedical Engineering

University of Texas at Arlington

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Zakia Mizan