
Vicky Teh
Technical Service Engineer

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About me
Quality Management Manager at B. Braun Medical
Education

University Tunku Abdul Rahman
2009 - 2013Bachelor's Degree Biomedical/Medical Engineering First ClassActivities and Societies: Engineering Society Academic AchievementsDean's List, January 2010 TrimesterDean's List, October 2010 TrimesterPresident's List, January 2011 TrimesterDean's List, October 2011 TrimesterDean's List, January 2012 TrimesterBook Prize Year 2013
Experience

Biomarketing Services (M) Sdn Bhd
Jul 2013 - Mar 2014Technical Service EngineerJob Responsibilities- Exposed to the operation of hospital laboratory department, which included hematology, histopathology, immunology and microbiology.- Understood the operation and able to operate BD FacsCalibur (flow cytometer), Bio-Rad IH1000 (automated blood screening system), Celerus Wave System (automated rapid IHC), Phadia System (allergy and autoimmunity diagnostic tests), centrifuge, incubator and blood mixer. - Maintained and troubleshoot all diagnostic and medical instrumentations.- Performed installation on all types of instrumentations.- Trained customers on basic maintenance of the equipment.- Kept machine downtime and customer’s complaint at the minimum.- Liaised with principals for warranty claims and major breakdown issue.- Prepared quotation as requested by customers. Show less

Fairchild
Mar 2014 - Jan 2015Process EngineerJob Responsibilities - Understand and analyse process in detail and improve process for ease of production run.- Modify equipment or equipment setting parameters to achieve targeted Overall equipment effectiveness (OEE).- Technical documentation on standard operating procedures (SOP), technical specifications, work instruction, out of control plan (OCAP) and one point lesson (OPL) to ensure process sustaining.- Initiate, lead and execute projects for cost saving, process improvement and quality enhancement.- Identify root cause, containment action, corrective action and preventive action for quality issue or customer return. - Generate 8D reports for quality issues.- Utilize TS-16949 core tools to eliminate risk in process, sustain the process and measure effectiveness of corrective or preventive actions.- Process owner for MSA, SPC and FMEA.- Liaise with vendor or supplier to ensure capability of equipment or incoming material in supporting production.- As Packing Engineer in creating packing drawings and ensure products packing meet EIA standards.Accomplishments - Team leader in Coplanarity/Bent Lead Improvement Project.- Collected statistically accepted amount of data.- Analyzed data and identified root cause by using pareto, 4M1E analysis and Why-Why analysis.- Identified action items and ensured action owners complete according to Gantt chart.- Technical documenting to ensure process sustainability.- Monitored effectiveness of project.- Reduced cost of lead rejects by 95%. Show less

B. Braun Group
Jan 2015 - now* Assure production compliance to standards, regulations and manufacturing SOPs. * Ensure quality compliance - Customer Complaint Processing (investigation, review, approval, answering customer inquiries), CAPA, Process Deviation, Auditing (internal and supplier), Change Control, Validation. * Decision making for non-conforming materials/ products disposition. * Risk assessment and hazard analysis for non-conforming products in market. * Six-sigma approach for cost savings projects. * Monitoring complaint trending and data analysis to take proactive counter measures. * Data analysis with ultimate aim of reducing customer complaint ppm. * In collaboration with global sales and marketing team to understand customer concern to reduce complaint due to handling error. * Risk analysis and risk management (FMEA). Show less Ensure quality system compliance through continuous improvement.• Coordinate and work closely with cross functional department to ensuresmooth implementation of quality management related activities.• Collect, analyse and summarize data to provide in-depth descriptions ofmanufacturing process anomalies.• Work as a team or lead the team in improving quality and reject reductionwith knowledge in driving good process control monitoring and qualityimprovement activities based on quality performance.• Lead auditor for internal and supplier audit.• Subject matter expert for risk management Show less Job Responsibilities: - Initiate, coordinate and participate in quality improvement activities/ projects.- Collect, analyze and summarize data to identify cause analysis to provide in-depth descriptions of manufacturing process anomalies.- Conduct trend analysis.- Coordinate and participate in non-conformance, customer complaint, CAPA root cause analysis and identify action plan.- Review non-conformance, customer complaint and CAPA report.- Moderator and reviewer for process risk analysis.- New product introduction core team member.- Support in second and third party audit.- Certified supplier auditor and conduct supplier on-site audits.- Project leader for supplier development program.- GMP and gowning procedure responsible person.Projects: (i) Supplier Development Program- Project leader for supplier development program.- Visit supplier and conduct gap analysis.- Identify supplier’s gap and room for improvement.- Propose, define and work together with supplier for action plan to address identified gaps.- Closely monitor the quality trend of supplier.- Arrange basic quality system training for supplier, which include introduction to ISO13485, root cause analysis, test specification, validation and good documentation practice.- Successfully improve supplier quality from rejection rate of >1.0% to <0.5%. (ii) Good Manufacturing Practice- Revamp the inspection system for gowning procedure.- Establish GMP poster to create and increase awareness. Show less Job Responsibilities:- Non-conformance, CAPA (Corrective action and preventive action) and customer complaint investigation.- Non-conformance, CAPA and customer complaint investigation report writing.- Injection moulding process verification and validation.- Injection moulding process parameters optimization.- Identify and implement process improvements.- Review and revise process FMEA.- Cost saving project leader.Projects:(i) Green Belt Projects- Reduced scrap rate for production parts.- Utilized six sigma tools as below:o DMAICo Paretoo Process Mappingo GRRo Process Capability Studyo Cause and Effect Matrixo Correlation Analysiso DOE- Identified the root cause and implemented corrective actions.- Successfully completed the project within timeline.(ii) TWI (Training within Industry)- Utilized TWI approach to reduce escapee of defective parts by ensuring effective and standardize training so that control plan is carried out as per SOP to contain defective parts. Show less
Manager - Quality Management
Apr 2024 - nowAssistant Manager - Quality Management
Apr 2021 - Jun 2024Senior Quality Engineer
Apr 2018 - Feb 2022Quality Engineer
Jul 2017 - Apr 2018Process Engineer
Jan 2015 - Jul 2017
Licenses & Certifications

Cleanroom Awareness and Requirements For Pharmaceutical Industry
PSDC (Penang Skills Development Centre)Jun 2018
Gauge Repeatability & Reproducibility
PSDC (Penang Skills Development Centre)Jul 2016
Biohazard Management
Diya Training & Development ConsultancyJun 2015
Certified Quality Engineer (CQE)
Argi Management Consultants Sdn.BhdApr 2019
Supplier Auditing
BSI Neville Clarke – A BSI Professional Services CompanyOct 2017
ISO 13485 Internal Auditor
BSI Neville Clarke – A BSI Professional Services CompanyAug 2018
ISO 13485:2016
BSI Neville Clarke – A BSI Professional Services CompanyJun 2018
ISO 13485 Certified Quality Management System Lead Auditor
SGSApr 2018
Six Sigma Green Belt (CSSGB)
Argi Management Consultants Sdn.BhdSept 2016
Training Within Industry (TWI)
TWI Institute HeadquartersJun 2015
Languages
- chChinese
- enEnglish
- maMalay
- caCantonese
- hoHokkien
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