Michael Lee Email & Phone Number

Singapore

• Responsible for strategic oversight and leadership direction within the QRA function for External Manufacturing in Asia – Pacific region which includes Greater China (China, Taiwan and Hong Kong), North Asia (Japan and.
• Manages a team of 5 direct reports and 28 professional employees in the APAC region (Singapore, Shanghai, Malaysia) responsible for the management, maintenance and continuous improvement of the ISO13485 Quality System.
• Responsible for development of processes and procedures to implement functional strategies and development of global dossier summary documents for various single used only and durable medical devices including but not.
• Provide Regulatory leadership in accordance with ISO 13485, MDSAP, EU MDR 2017/745 and United States FDA 21CFR, Part 820 & Quality System Regulations to assigned projects in respect to countries within APAC region to.
• Carry out management of Customer and Supplier Quality in APAC including qualification of new Suppliers, routine audits, product inspections, ongoing surveillance, Post Market Surveillance (PMS) and review of.
• Review and approve contract sterilization of products which includes: Oversight on dose mapping, dose audits, product release (Gamma Irradiation and EtO), Support cycle qualification, and etc.

Singapore

• Provided leadership, focus and direction for the Singapore manufacturing plant that produced premium quality Life Science Instruments, Calibrator Plates and Reagents and being the Global Repair Centre.
• I have played key managerial leadership roles in clinical and commercial manufacturing, technology transfers and commissioning/validation.
• Provided leadership for product launch, scope definition, and technology transfer strategy, staffing of start-up teams, as well as, preparation of Commissioning test documents, Installation (IQ), Operation (OQ) and.
• Provided extensive technical leadership in the areas of process scale-up and technical transfers during the development of innovative platforms by integrating facility design, process development, and manufacturing.
• Led activities of multiple projects within the constraints of aggressive timelines and a cGMP regulated environment. Played key leadership roles in equipment prototyping, technology transfers, resolution of deviations.
• Reporting to the Senior Site Director with direct reports including 2 Production Managers, 5 Supervisors and Engineers. Managed an annual operating budget of over US$5 million and 90 employees.

Singapore

Brought on board to join the Company’s Initial Public Offer (IPO) team and to manage pivotal financial turnaround for a contract equipment manufacturer with US$40 million in sales and 140 employees. Charged with correcting operational issues that negatively affected production, profit, and morale. Directing regional operations which include manufacturing.

Singapore

Was recruited in 1995 and assigned to lead and manage the Printed Circuit Board Assembly (PCBA) manufacturing plant. Charged with correcting operational issues that negatively affected production and to revamp the entire manufacturing operation in the Rigid and Flex PCBA plant. Reporting to the General Manager with 3 direct Managers reporting to me each.

Singapore; Batam

Was recruited in 1989 for Singatronics Limited R&D and Printed Circuit Board Assembly (PCBA) expansion program. Manage multi-site projects for order fulfillment, manufacturing development, and capacity scale-up. In 1993 led a pioneer team to Batam, Indonesia to start up a 16000 Sq. Ft new production factory successfully. Develop local manufacturing plans.

Singapore

I joined Matsushita Denshi Integrated Circuit (IC) Division in 1981 and was assigned to take charge of the Transfer Moulding, Trim & Form, and Marking Department. I was trained in Japan on various IC manufacturing processes including Bonding and Molding. Upon return from Japan, I was responsible for the setting up of the Integrated Circuits department in.

Master, International Business

Higher National Diploma, Mechanical Engineering

Full Technological Diploma (Mechanical Engineering)

Diploma, Mechanical Engineering

Gce 'O' Level, Gce 'O' Level