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About Me

A well-diversified medical device professional with over 15 years of experience specializing in the areas of quality system regulations, lab service operations, supply chain logistics, medical device development & design processes combined with extensive exposure to Project Management technologies

Specialties

•Laboratory Service Operations

•Leadership and People Management

•      Supply Chain & Logistics

•ISO 13485 and FDA Compliance

•Medical Device Labeling

•Process Development

•Documentation Development and Report Writing

•Test Verification & Validation

•QC Inspection & Testing

•Problem Solving and Analysis

Education

1978Present

Geylang Serai Vocational
2009

Humber College
1999

Humber College
19781986

Apprenticeship

Singapore Airlines

Work experience

Apr 2013Present

Supply Chain Logistics Manager

Thornhill Research Inc.

Responsibilities

Responsible for supply chain and logistics operations for R&D and manufacturing of medical equipment systems; supplier qualification / management, procurement strategies, parts sourcing, pricing negotiation, shipping and packaging, delivery schedules, RMAs and inventory management  Supplier liaison to ensure all purchase orders are fulfilled, delivery schedules are tracked, documentation are complete when parts are received to keep production timeline on schedule Active member / participant of Change Control Board (CCB) meetings to address non-conforming issues

May 2010Aug 2012

Manufacturing Quality Control Specialist

Sentinelle Medical - Division of Hologic Inc.

Responsibilities 

Review and approval of all manufacturing device records of Magnetic Resonance Imaging (MRI) Systems and providing shipment release authorization per QMS requirements to ensure ISO 13485 and FDA 21 CFR Part 820 compliance Development, implementation and training of employees on Good Documentation Practices in accordance with GMP Tracking (Device History Records) DHR issues and providing recommendations for resolving the issues and preparation of monthly DHR issues metrics for reporting to management. Safekeeping and tracking of all DHR documentation and implemenatation of an off-site archiving process Providing guidance and feedback to manufacturing for development of process and validation documentation Providing guidance to the IPC (Association Connecting Electronic Industries) trained manufacturing technician in development of training materials per the requirements of IPC J-STD-001 standard, for presentation and co-trained employees to the requirements

Aug 2009Apr 2010

Production Supervisor

Mui Scientific Incorporated

Responsibilities

Supervision of manufacturing activities of water perfused manometric infusion pumps and catheters and providing technical service support to customer for all supported products and new development activities

Reviewing / updating manufacturing documentation and implementing of quality inspection criteria to conform to regulatory compliance requirements

Feb 2000May 2008

Lab Services Team Lead / Mechanical Technologist

Vasogen Incorporated

Key Responsibilities & Accomplishments

Setup, facilitated transfer, provided infrastructure and managed 2500ft2 Electro-Mechanical test lab by establishing and implementing laboratory safety requirements, inventory management, bio-hazardous waste management, providing training to lab users, ensuring test instrument calibration was up-to-date, conducting ESD and Lab Safety audits to ensure smooth operation, employee health and safety and regulatory compliance

Highlights

Spearheaded labeling project for device use in Clinical Trials and European Union (EU) commercialization in compliance with standards and regulations including Medical Device Directive (MDD), Food & Drug Administration (FDA) and International Labeling Requirements

Initiated efforts to improve lab operations activities to promote a safe workplace; established and chaired monthly lab steering committee to address lab objectives, continual improvement initiatives and issues

Technical Responsibilities

Developed requirements and test protocols, write reports, created test jigs and conducted tests to evaluate functionality of electro-mechanical components and devices

Executed Failure Mode Effect Analysis (FMEA), First Product Acceptance Test (FPAT), Verification and Validation (V&V), incoming quality inspections to verify devices and products meet performance requirements

Performed investigations relating to Non-Conformance Material Reports (NCMR) and Corrective Actions Preventive Actions (CAPA) to resolve issues relating to product failures and customer complaints; generated reports and provided recommendations

May 1994Dec 1999

R&D Technologist

Vas-Cath Incorporated

Highlights

Prevented inventory backorder of angioplasty catheter production by successfully redefining process parameters for problematic sizes of angioplasty balloons; resulted in yield increase of angioplasty balloons to above 80%

Received commendation for taking initiative to evaluate and resolve issue of failed balloon tubing qualification; resulted in substantial material costs saving through reuse of many rejected balloon tubing lots which previously failed qualification

Responsibilities

Provided design input for development of higher pressure strength, multi-layered balloon that exceeds competitors’ capability; resulted in timely release of new product line of CenturionTM catheters to market

Provided technical support and innovative balloon development techniques to Research and Development design team in development of angioplasty balloons used in angioplasty procedure

Dec 1978Jan 1994

Acting Lead Aircraft Technician

Singapore Airlines Limited

Overview

FAA A&P (airframe & powerplant) certified mechanic with more than 10 years of loyalty service with Singapore Airlines performing service and maintenance of B747-200, -300, -400, B767, B757, B737, B727, B707, A310, A300 and MD11 series commercial airplanes (engines types included Pratt Whitney, Rolls Royce and General Electric jet engines)

Experience

Executed aircraft airframe, engine, landing gear and hydraulic system checks; removal, installation and troubleshooting of components such as ailerons, spoilers, actuators, elevators and rudders, fuel pump, hydraulic components, lines, constant speed drive (CSD) and integrated drive generators (IDG), starters, engine magnetic plugs, igniter plugs, wheel and brake changes, etc

Performed inspection, removal, installation and repair of all cabin interior components such as cockpit windows, cockpit seats, passenger windows, passenger seats, seating recline mechanism and storage compartment mechanism, etc

Experienced in performing “Transit” and “Stayover” maintenance (refueling, inspection, wheel and brake change, troubleshooting and rectification of aircraft problems in a timely manner to ensure aircraft departed on schedule) 

Performed all kinds of assembly works according to blueprints with experience operating various kinds of electrical, mechanical and pneumatic tools and computer controlled equipment

Led crew (3-7 mechanics) to handle flights on their transit stop-over, layover maintenance checks, Auxiliary Power Units (APU) changes, 5th Pod Engines removal and installations

Supervised and trained apprentices and trainees during their on-the-job training in aircraft maintenance