KEMBAR78
Winnet Resume | PDF | Quality Management System | Medical Device
Scribd
Upload
95 views1 page

Winnet Resume

Winnet Murahwa has over 3 years of experience in quality assurance, focusing on regulatory compliance, product quality improvement, and defect reduction. Currently, they work as a Safety Regulatory Reporting and Global Complaints Analyst at ICU Medical, where they analyze safety data and prepare regulatory reports. Their previous roles include Quality Assurance Specialist at Abbott Labs and Quality Engineer at Becton Dickinson, where they conducted audits, root cause analysis, and developed quality control procedures.

Uploaded by

jesusmysaviour333
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
95 views1 page

Winnet Resume

Winnet Murahwa has over 3 years of experience in quality assurance, focusing on regulatory compliance, product quality improvement, and defect reduction. Currently, they work as a Safety Regulatory Reporting and Global Complaints Analyst at ICU Medical, where they analyze safety data and prepare regulatory reports. Their previous roles include Quality Assurance Specialist at Abbott Labs and Quality Engineer at Becton Dickinson, where they conducted audits, root cause analysis, and developed quality control procedures.

Uploaded by

jesusmysaviour333
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 1

Winnet Murahwa

Phone: 801-651-3581 winnmurahwa@gmail.com Vineyard, UT, 84059

PROFESSIONAL SUMMARY:

● Over 3 years of experience in quality assurance field with ensuring compliance with regulatory requirements,
improving product quality, and reducing defects.
● Experience in conducting root cause analysis, implementing corrective and preventive actions, and
leading quality improvement projects.
● Strong communication skills and ability to work collaboratively with cross-functional teams.

PROFESSIONAL EXPERIENCE:
Safety Regulatory Reporting and Global Complaints Analyst ICU Medical (UT) May 2024-Present

● Conducted in-depth safety data analysis to identify adverse events and trends with Medical Devices.
● Prepared and submitted regulatory reports (eMDR's) to the FDA.
● Conducted Decision Trees to determine Reportability to streamline safety reporting workflows.
● Utililised softwares such as Trackwise, Agile, and SalesForce for quality system processes.
● Conducted internal and supplier audits to ensure compliance with ISO 9001 standards and regulatory requirements.

Quality Assurance Specialist Abbott Labs– IL(Remote) Jan 2022 - Mar 2023

● Conducted internal and supplier audits to ensure compliance with ISO 9001 standards and regulatory requirements.
● Assisted cross-functional teams in root cause analysis and problem-solving activities.
● Developed and maintained quality metrics to track performance and identify opportunities for improvement.
● Utilized Agile software for quality system processes.
● Conducted complaint reports through electronic Medical Device Records (eMDRs), (EU MDRs).

Quality Engineer I Becton Dickinson – SLC, UT Apr 2019 – Aug 2020


● Developed and maintained quality control procedures and work instructions to ensure consistent product quality.
● Assisted in the development and implementation of a new quality management system (QMS) based on ISO 9001
standards.
● Conducted internal audits to assess compliance with QMS requirements and identified opportunities for
improvement.
● Participated in cross-functional teams to investigate and resolve quality issues.
● Utilized CAPA's to investigate product, quality problems, and taking appropriate and effective corrective and/or
preventive action.
● Utilized engineering software Trackwise, JDE and MasterControl for quality processes.

Quality Assurance Specialist II Becton Dickinson – Sandy, UT Oct 2017 – Nov 2018

● Conducted complaint reports utilizing trackwise software through electronic Medical Device Records
(eMDRs), (EU MDRs).
● MDR Vigilance Reporting, Post Market Surveillance, Product Complaint and Product Reporting.
● Investigations, Medical Device Reporting (MDR), Document Control, CAPA, Root Cause Analysis and
Product Quality.
● Good knowledge of International reporting: MDV and BSI (European Economic Area), MDPR (Canada),
PMDA (Japan).

EDUCATION: Bachelor of Science in Biochemistry (Brigham Young University Hawaii)

You might also like