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