In charge of medical PCBA product for Abbott customer, and provide support to Abbott box build product.
Handling different product level of PCBA board inclusive of simple board (1000 components).
Supporting daily production line quality issue.
Communicating and dealing with customer on product inquiry and quality related issue.
Perform line audit to ensure that the product build is meet FDA medical requirement.
Perform activity like; raise purge notice, develop FMEA and PCP, preparing FAR report and NPI checklist, and signing off ECO changes.
Dealing with customer complaint and respond to customer CAR.
Lead the CFT team on solving the quality issue and propose on any area for improvement.
Review validation report which consists of IQ, PQ and OQ process.
Industry: Manufacturing / Production
Specialization: Quality Control/Assurance
Role: Quality Control/Assurance
Position Level: Senior Executive
Achievement (Certified with below standard):
Root Cause Analysis (RCA), Corrective Actions and Preventive Actions (CAPA), Utilizing 8 Disciplines (8D) Methodology.
Understand ISO 13485:2016 Medical Devices-Quality Management Systems- Requirement For Regulatory Purposes & Process Approach Internal Auditor Training.
ISO 13485/ QSR/ PMDL Quality Auditor.
ISO 13485/ QSR/ PMDL Medical Standards Requirements.
US FDA 21 CFR Part 820 QSR & part 11
Six Sigma Yellow Belt.
Six Sigma Blue Belt.
Six Sigma Green Belt(pending for exam result)
Reason for leaving current company: Looking for more challenging environment and career path growth.
Quality Engineer
Jabil Circuit Sdn. Bhd.
01.2013 - 04.2016
In charge of ICT fixture product for ECT customer.
Participate and attend product transfer training at customer side in Singapore.
Handling with complex electronic product which include of mechanical part and complex wiring process (500 – 4000pcs of wiring).
Performing strain gauge measurement on the ICT fixture as per customer Specification.
Participate in APQP qualification process which involve of FMEA, PCP and RMA process.
Define quality inspection process flow and develop quality inspection checklist.
Dealing with customer complaint and respond to customer CAR.
Ensure the entire QA inspection process is running smoothly.
Handling with SAP PLM software to checking on the inventory for purge activity.
Industry: Manufacturing / Production
Specialization: Engineering - Others
Role: Others
Position Level: Senior Executive
Reason for leaving current company: Being in Penang, Malaysia since graduated, hence I think it’s time to search for an overseas career exposure to increase my skills and knowledge and finally get a job offer from Singapore.
Process Engineer
Plexus Manufacturing Sdn Bhd
04.2010 - 01.2013
In charge of 80 model of aerospace project for Honeywell customer (PCBA).
Handling different product level of PCBA board inclusive of simple board (1000 components).
Certified with ISO 9001 standard and ISO14001 standard.
Support aerospace protocol activities and documentation processes.
Lead a team for NPI start-up and improvement activities.
Liaise with customers and internal team on process engineering related activities.
Responsible for quality, yield and cost in process engineering.
Responsible for line set-up and qualification of manufacturing process.
Define acceptable process yields for critical processes as well as troubleshoot line and process-related issue.
Doing Kaizen improvement activities project.
Provide FMEA and PCP for process improvement control.
Perform conformal coating process and bonding process for PCBA board and perform inspection to ensure the final product meets the IPC-610 standard.
Industry: Electrical & Electronics
Specialization: Engineering - Electrical
Role: Process Engineer
Position Level: Junior Executive
Reason for leaving current company: I have learnt a lot with Plexus as a fresh graduate, my learning reached a stagnant stage in this company hence decided to try a new role as QA in hope that my process experience will add value to the QA role.
Education
Bachelor's Degree in Engineering - Material Science
Product Development Engineer at AMS OSRAM - OSRAM Opto Semiconductors (M) Sdn. BhdProduct Development Engineer at AMS OSRAM - OSRAM Opto Semiconductors (M) Sdn. Bhd