Summary
Overview
Work History
Education
Skills
Leadership and Volunteer Activities
Timeline
Generic

Jousiana Hanna

Brick

Summary

Hard-working, driven individual with excellent communication and problem-solving skills. Adaptive personality and quick learning ability value to cross-functional teams and independent projects.

Overview

5
5
years of professional experience

Work History

Process Engineer II

Integra LifeSciences
01.2022 - Current
  • Drive the implementation of six sigma methodologies in the characterization of process to ensure robust and well identified CTQs.
  • Responsible for project management, process development, process improvement, IQ/OQ//PQ validations, developing and meeting transfer goals and metrics, optimization of the transfer process to ensure that new equipment and processes are delivered in an efficient, timely, and compliant manner with robust manufacturing processes.
  • Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full scale manufacturing working with outside suppliers.
  • Ensure that all appropriate documentation, drawings and specifications are generated in compliance with Integra’s procedures and statutory requirements (US FDA and ISO) under current change control procedures as required.

Quality Engineer II

Getinge
05.2019 - 12.2021
  • Ensures compliance with FDA requirements in regards to Intra-Aortic Balloon Pumps manufactured on-site.
  • Investigates and resolves identified non-conformances through Corrective and Preventive Actions (CAPA), Non-Conforming Material Reports (NCMR), Audit Observations (Internal and External), Design Changes, and Change Notices.
  • Responsible for writing protocols, installation qualifications (IQs), Test Method Validations (TMVs), Gauge R&R, Quality Control Inspection procedures, and Standard Assessments
  • Supports Quality Management and Quality Initiatives thorough facilitating 3 process improvements, decreasing overall errors by 15%

Education

Master of Science - Engineering Management

New Jersey Institute of Technology
Newark, NJ
05.2023

Bachelor of Science (BS) in Biomedical Engineering -

New Jersey Institute of Technology
Newark, NJ
05.2019

Certifications -

Six Sigma Green Belt
02.2024

Skills

  • Systems, Applications, and Products Software (SAP)
  • BMRAM, and Minitab
  • Trackwise, Windchill Quality Management System
  • Microsoft Office (Word, Excel, PPT, Project)
  • Solidworks
  • Data Analytics
  • Root Cause Analysis
  • Risk management
  • Project Planning & Project Management
  • Resource Management
  • Lean Manufacturing and Design
  • Purchasing and Procurement

Leadership and Volunteer Activities

Integra LifeSciences

  • Project management, process development, process improvement, IQ/OQ//PQ validations, developing and meeting transfer goals and metrics, optimization of the transfer process to ensure that new equipment and processes are delivered in an efficient, timely, and compliant manner with robust manufacturing processes.
  • Lead, support, and participate on special operations improvement projects.

Getinge

NCMR Process Owner

  • Owner and Leader of the Non-Conforming Material Process at Getinge Manufacturing Site
  • Supervises and oversees all identified Non-Conformances during incoming inspection, production, and packaging
  • Conducts weekly meetings for site managers, and monthly metrics meetings for state directors and Vice President

Quarantined Product Process Owner

  • Owner and leader of the Quarantined products due to FDA Recalls, NCMRs, and Protocols
  • Designated key-holder to maintain and document forms in regards to the activities within the Quarantine cage



Timeline

Process Engineer II

Integra LifeSciences
01.2022 - Current

Quality Engineer II

Getinge
05.2019 - 12.2021

Master of Science - Engineering Management

New Jersey Institute of Technology

Bachelor of Science (BS) in Biomedical Engineering -

New Jersey Institute of Technology

Certifications -

Six Sigma Green Belt

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Jousiana Hanna