Senior Quality Assurance Specialist

• Feb 2022 - Present

Quality System Coordinator (Global)

• Oct 2018 - Dec 2021

Daniels Health (Global) has been market leader for 30 years in medical waste solutions to make healthcare safer. Its flagship product reusable sharps containment system (to protect healthcare workers from needlestick injuries and infection) is estimated to be the most widely used in the world and is arguably the world’s safest and most environmentally-responsible sharps management system. My role is to establish, implement, maintain and improve Daniels global quality management system in compliance to quality (ISO13485), regulatory and industry standards requirements (primarily in US (FDA), Canada, UK, Australia). My key responsibilities include the followings: • Regulatory submission for new products and product changes • Coordinate and support on-site audit from external auditors (notified bodies / regulators) • Creation and maintenance of DHF, DMR and DHR • Provide quality assurance for company's products and processes covering outsourced manufacturing/services • Monitor risk management activities and maintain risk management files • Establish & maintain Validation Master Plan, establish validation protocol and reports for manufacturing equipment/process and computerised systems working together with cross-functioning team • Verify/validate Daniels products and processes (including Microbiological, Biocompatibility test, sterilization process ie. Gamma Irradiation, Ethylene Oxide, reusability/reprocessing of medical device) • Manage change control, document and record control • Provide approval to supplier and QA release for production lots • Develop and implement training program • Conduct internal and external audit • Manage customer complaints, reporting to regulatory for adverse quality events, non-conformance, Corrective and Preventive Actions • Continuous improvement for products, processes and QMS Show less

Quality and Business Process Engineer

• Dec 2009 - Oct 2018

SRXGlobal has been Electronic Manufacturing Services (EMS) provider in diverse markets for 25 years who enables OEMs to advance innovative, custom-made electronic products for technology markets. My roles and responsibilities were to maintain and improve quality management system in compliance to ISO13485, ISO9001 and FDA 21 CFR Part 820 QSR, create and maintain Device Master Record (DMR) and Device History Record (DHR), provide quality assurance strategy and plan for customers, manage non-conformances and supplier quality, implement lean manufacturing and promote culture of continuous improvement. Show less

Technology Development Platform Manager

• Jan 2006 - Jul 2009

• Led and managed platform technology development program consisting of semiconductor, package, board and system ingredients to deliver technology readiness per targeted resource, schedule, quality and cost to enable critical product launch into High Volume Manufacturing• Accountable for technology path finding, definition, development, certification, deployment and transfer to multiple high volume manufacturing sites at OEMs/Electronic manufacturing sub-contractors

Technology Development Platform Integrator

• Jan 2004 - Dec 2005

Responsible for SMT and Second-Level-Interconnect Solder Joint Reliability activities involving in developing SMT collaterals/jig/fixtures, designing DOE, performing feasibility study on technology options, simulating test conditions, characterizing process/material/reliability behaviors, validating technology solutions, collecting empirical data and driving improvement

Thermal Mechanical Development Engineer

• Feb 2003 - Dec 2003

Develop, characterize and improve thermal enabling solution for Second Level Interconnect Reliability certification for various segments (Desktop, Server, Communications and Mobile)

SMT Module Development Engineer

• Jan 2001 - Jan 2003

• Set up, develop, certify and ramp advanced SMT module technology capabilities to support high-speed interconnect product launch into High Volume Manufacturing for various segments (Desktop, Mobile, Server, Wireless and Telecommunications)• Collaborate with OEMs/sub-con to ramp Intel boards by delivering technical collaterals, generating SMT course content and proliferating SMT knowledge• Generate SMT training module for Corporate Quality Engineering team

SMT, NPI and Product Transfer Engineer

• May 1999 - Dec 2000

• Start-up and ramp-up New Products into High Volume Manufacturing (HVM) and transfer to electronic manufacturing sub-contractors• Sustain and continuously improve SMT performance in yield, quality, productivity and cost through continuous improvement projects and poke-yoke• Manage and maintained product engineering documentation including BOM, SOP, drawing and schematics