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 Korea), South East Asia, South Asia, Middle East, Australia and New Zealand. • 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 which includes controlled documents, procedures, forms and work instructions. I am the principle point of contact for competent authorities in relation to the Quality System in APAC.• 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 limiting to Personal Protection Equipment (PPE), Electro-Mechanical Devices, Traditional and Advanced Wound Care closely with cross-functional stakeholders • 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 drive Quality and Regulatory Affairs Management and Quality matters. • 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 performance to ensure products produced under agreements with Cardinal Health meet all quality and regulatory requirements.• 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.• Appointed as Management Representative for Cardinal Health (APAC).

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 Performance (PQ) Qualification protocols for the instruments manufactured. • 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 resulting in substantial capital and cost of goods savings. • 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, and routine operations troubleshooting. • 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, materials management, product costing and quotations, financial reporting, human resources, information systems, and sales/marketing. I took responsibility for all manufacturing and engineering areas of the operation, in addition to provide facilitator and coordination functions for construction of brand new facilities, expanding, upgrading, remodeling existing facilities and continue with transition projects from other locations to the facility, including surface mount automated assembly, laser printing, automated visual inspection and equipment manufacturing. Managed the Sub-Contract business with full revenue and profit responsibility. I possess excellent strategy, planning and execution and demonstrated success in delivering real business benefits. Demonstrated success in leading business transformations that focused on increased revenue and profits.

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 heading a department; Manufacturing Dept., Engineering Dept. and Production Planning & Control Dept.). Together we managed an annual operating budget of over US$8 million and 480 employees producing about 2 million units of various PCBAs per month.

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 and schedules and confirm alignment with parent facility master schedule. Identify, justify and source capital equipment for start-up Surface Mount Technology (SMT) operation. Establish supply chain for regional sourcing of raw materials and strategic partners for process outsourcing & production equipment. Reporting to the General Manager with 2 Production Superintendents and 9 Supervisors as direct reports and a total manpower of 250. Took charge of the manufacturing department that includes SMT, Through Hole, In-Circuit Test, Functional Test, Box Build, Maintenance and Production Control & Scheduling functions.

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 the new Ang Mo Kio factory. Fully responsible for the day to day operations of IC manufacturing to meet all the KPIs set for production and product quality. In Jan. 1984, I was sent to Japan for three months training on IC bonding (die and wire bonding) machines and new products (Logic Devices) transfer to Singapore. In Jan. 1986, promoted to the rank of Senior Supervisor taking charge of the End of Line operation. (Trim & Form until Final Packing). In Jan. 1987 I was sent to Japan for three months training in Middle Management and Industrial Engineering. Upon return set up a new section that focus on the product costing and standard time and in July 1987, I was promoted to the rank of a Senior Engineer taking charge of the new section. Subsequently in July 1988 promoted to Section Head.

Master, International Business

Higher National Diploma, Mechanical Engineering

Full Technological Diploma (Mechanical Engineering)

Diploma, Mechanical Engineering

Gce 'O' Level, Gce 'O' Level