Select and manage ongoing relationships with suppliers and vendors to ensure the organization receives satisfactory standards of service. Introduce and develop the integration of new technology into the current lab processes to increase productivity, cost effectiveness, quality of work and enhance the capability of the team.
Lead the establishment of objectives, policies, standards and strategies in operational support best practices. Support in the development, modification, verification and validation of test method. Hold the authority in approval of Test Report, IMS document, Quality Reports (CAPA, NCIR), Document Template,Validation Plan and Report, IMTE RA report, obsolete test equipment and jigs.
Have the authority and resources to implement, maintain and improve the management system, identify deviations from the management system or from the procedures for performing laboratory activities, initiate actions to prevent or minimize deviations, report to laboratory management on the performance of the management system and any need for improvement, and ensure the effectiveness of laboratory activities. Ensure laboratory operation and projects are compliance to specification and relevant standard regulations, as well as ISO/IEC 17025, ISO 13485 and FDA quality system requirements.
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Select and manage ongoing relationships with suppliers and vendors to ensure the organization receives satisfactory standards of service. Introduce and develop the integration of new technology into the current lab processes to increase productivity, cost effectiveness, quality of work and enhance the capability of the team.
Lead the establishment of objectives, policies, standards and strategies in operational support best practices. Support in the development, modification, verification and validation of test method. Hold the authority in approval of Test Report, IMS document, Quality Reports (CAPA, NCIR), Document Template,Validation Plan and Report, IMTE RA report, obsolete test equipment and jigs.
Bachelor Degree in technical with hands-on experience managing day-to-day lab test equipment, calibration, maintenance, and validation.
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Estimate the costs, resources, and time required to implement the organization’s annual goals and monitor the performance of projects to ensure targets are met.
Select and manage ongoing relationships with suppliers and vendors to ensure the organization receives satisfactory standards of service.
Introduce and develop the integration of new technology into the current lab processes to increase productivity, cost effectiveness, quality of work and enhance the capability of the team.
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Work closely with Product Development team to understand customer needs and identify target area of technology exploration.
Lead, plan and organize the resources for early innovation exploration, fundamental research on new concepts or designs, materials and processes based on RD visions and strategy.
Conduct practical feasibility work in accordance with the requirements of the environmental, occupational health and safety management systems as appropriate.
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Schedule, perform, and document routine maintenance for manufacturing and test equipment while interpreting schematics, assembly drawings, and datasheets for testing and troubleshooting.
Assist in failure analysis, troubleshooting, and repair of non-conforming products, including preparing detailed Failure Analysis Reports to identify root causes.