Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Online Webinars
References
Hobbies and Interests
Timeline
Generic
KHAIRUNNISA RADZI

KHAIRUNNISA RADZI

Summary

Driven Quality Engineer with knowledge of quality and process change documentation in Medical Device lndustry. Organized and successful at managing priorities with positive attitude. Ready to help team achieve company goals.

Overview

4
4
years of professional experience

Work History

MDR Quality Engineer

Teleflex Medical Sdn Bhd
04.2021 - 06.2022
  • Updated of MDD/MDR Technical file for DEKRA Audit Initiate
  • Initiated and maintained of UOUP documents
  • Led clinical evaluation updates by doing assigned project of sample testing
  • Researched market and defined PMS Plan, PMS and PSURs activity
  • Prioritized remediation per relevant standard to achieve MDR compliance
  • Updated Risk Management Activity, for example Hazard Analysis report
  • Ensured compliance of all practices to the Quality Management System
  • Supported Regulatory Affairs
  • Collaborated with external auditors during annual reviews, ensuring a seamless audit process with minimal findings or discrepancies noted.
  • Led problem-solving activities to quickly identify and permanently resolve quality and productivity issues.

Process cum Quality Control Executive

Leonix Sdn Bhd
06.2019 - 03.2021
  • Established validation standards, develop testing protocol, prepare measuring equipment, methods, document results and maintained records
  • Reduced product defects through thorough inspections and strict adherence to company standards.
  • Increased customer satisfaction with timely resolution of complaints, ensuring product consistency and reliability.
  • Conducted root cause analyses to determine sources of product non-conformance, implementing corrective actions accordingly.
  • Maintained cleaning room
  • Performed & calibrate all equipment used in manufacturing
  • Verified incoming material, first piece product and final inspection
  • Specified quality requirements of raw materials with suppliers
  • Inspected products and worker progress throughout production
  • Carry out inspection and testing to evaluate the precision and accuracy

Research Internship

UDA Materials Sdn Bhd
09.2018 - 11.2018
  • Researched, gathered, analyzed information and documentation about global plastic recycling, the process and the issues to the environment
  • Researched on biodegradable & biopolymer packaging

Education

Bachelor of Technology (Bioresoures, Paper & Coating) -

Universiti Sains Malaysia
02.2019

Diploma in Laboratory Technology -

Universiti Pendidikan Sultan Idris
11.2015

Skills

  • MS Office, MS Excel, MS Power Point, MS Outlook
  • Venture 3D CNC - Baty Fusion Software
  • ISO 13485
  • Quality Documentation
  • Quality processes
  • Team Leadership
  • Documentation And Reporting
  • Attention to Detail
  • International regulatory compliance
  • Attention to detail and accuracy

Accomplishments

  • Medical Device Regulation(MDR)

Went through the meticulous process of updating within the latest compliance. Received excellent grades of the approach I recommended for case studies.

  • Collaborated with team of 6 in the development of testing sample for respiratory product.

Languages

BahasaMelayu
Proficient
C2
BahasaInggeris
Advanced
C1
Arab
Intermediate
B1

Online Webinars

Industry Expert Sharing on Bioburden Sterility

References

  • Nurul 'Afifah Mohd Yusoff, Senior Eng. at Teleflex Medical (019-2950452)
  • Dr Mazlan Ibrahim, Lecturer at USM

Hobbies and Interests

  • Volunteering Work
  • Travelling, Mobile Videoghapher

Timeline

MDR Quality Engineer

Teleflex Medical Sdn Bhd
04.2021 - 06.2022

Process cum Quality Control Executive

Leonix Sdn Bhd
06.2019 - 03.2021

Research Internship

UDA Materials Sdn Bhd
09.2018 - 11.2018

Bachelor of Technology (Bioresoures, Paper & Coating) -

Universiti Sains Malaysia

Diploma in Laboratory Technology -

Universiti Pendidikan Sultan Idris

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KHAIRUNNISA RADZI