Muhammad Ali Aizat Abu Bakar

Biomedical Engineer with 2-year experience performing various quality assurance and quality control for medical electronics. Possess Bachelor’s in Biomedical Engineering and knowhow in medical device life cycle, specializing in high risk ICU and OT environment. Looking to leverage my experience in engineering role that related to regulatory affairs, for the pharmaceutical/medical device manufacturing.

QA/QC Engineer, Biomedical (Contract) 9 month // Dec 2021 – Aug 2022

*Cooperate with Conformity Assessment Body (CAB) & suppliers for medical device  certification with MDA. 
* Support QA during audits and regulatory inspections, QC team and other regulatory process teams as necessary to achieve compliance towards the regulatory affairs milestones. 
* Execute annual technical reviews of supplier to ensure appropriate risk mitigation and compliance with ISO13485, GDPMD and FDA for MDA-certified medical devices. 
* Participating in the supplier selection and evaluation process, conducting reviews or evaluations against established tender requirements in accordance with healthcare providers. 
 

Junior Engineer, Biomedical (Contract) 1 year // Nov 2020 - Oct 2021

* Manage the investigation and resolution of supplier quality issues in a timely manner to ensure  continuity of medical device unit, accessories, and spare parts in the inventory. 
* Collating supplier’s product quality & performance data for reporting to key stakeholders. 
* Training clients on medical device application & handling. 
 

Biomedical Technician (Internship) 4 month // Jul 2020 – Oct 2020

* Facilitate T&C, PPM and breakdown for various medical devices and respective system. 
* Championing problem-solving efforts and root cause analysis activities with suppliers for medical device maintenance issues to eliminate the recurrence of non‐conformances. 
* Coordinate client, supplier, concession and inventory in the planning and execution of procured medical device qualification to support engineering activities as required.

UNIVERSITI MALAYA (UM)    Sep 2017 – Dec 2023

Bachelor’s in Biomedical Engineering   

Graduating in December 2023   

CGPA: 3.28