Assistant QA Engineer

Position Summary • Provide technical and operational support for QC equipment, testing systems and related processes to ensure reliable, efficient and compliant QC operations. • Responsible for the management, maintenance, calibration and qualification support of QC equipment and assets throughout their lifecycle, including equipment selection, purchase, installation, setup, qualification and replacement. • Support QE/QA Engineers in equipment and process validation, troubleshooting, continuous improvement and procedure development/update. • Drive practical improvements to QC testing processes, tools, jigs and fixtures to improve testing efficiency, quality and operational effectiveness. Responsibilities • Manage and maintain QC equipment, tools and testing systems to ensure they are available, reliable and fit for intended use. • Maintain QC equipment calibration status, calibration range and equipment condition within specified requirements. • Monitor and coordinate suppliers/service providers for equipment repair, calibration, preventive maintenance and on-site servicing, ensuring work is properly completed and documented. • Maintain accurate QC equipment asset records, including equipment identification, location, status, calibration and maintenance history. • Review equipment performance and calibration results and recommend repair, replacement or other appropriate actions when equipment performance or calibration range approaches defined limits. • Support QE/QA Engineers in the evaluation, purchase, installation, setup, commissioning and qualification of new QC equipment, tools and testing systems. • Support equipment and process qualification/validation activities, including preparation and execution of relevant qualification documentation and follow-up of identified issues. • Establish, review and update equipment-related procedures, work instructions, forms, engineering drawings and other controlled documentation to reflect current requirements and actual practices. • Support QC troubleshooting and resolution of equipment- and testing-related issues to minimize disruption to routine QC operations. • Support QC continuous improvement initiatives to improve testing efficiency, quality, equipment reliability and operational effectiveness. • Design or support the development of simple jigs, fixtures and other tools to improve QC testing efficiency, consistency and quality. • Perform hands-on support for IQC and IPQC inspection activities when required, identifying gaps between documented procedures and actual practices and supporting appropriate updates. • Work closely with QC inspectors and QC leaders to understand operational needs and improve testing methods, equipment usability and work processes. • Support compliance with applicable QMS, cGMP and regulatory requirements related to QC equipment, testing and manufacturing activities. Requirements • Nitec or Diploma in Mechanical/Industrial/Manufacturing Engineering or equivalent. • 1-3 year of work experience in manufacturing. Exposure under the medical device manufacturing will be added advantages. • Good mechanical or industrial aptitude and knowledge. • Basic MS office skills and computer skills. • Possess positive mind set and willingness to learn. • Ability to communicate with Asian Inspectors on drawings, work instructions and etc. • Understand calibration certificate and requirement • Good knowledge of manufacturing processes on its documentation requirement and quality system. • Able to perform ad-hoc/festive season overtime due to manpower shortage