QC Equipment & Process Support Specialist

Biosensors Interventional Technologies Pte Ltd; Singapore; On-site; SGD 31,000 - 51,000; Full time

Job summary

Biosensors Interventional Technologies Pte Ltd in Singapore is seeking a QC Equipment Support Specialist to oversee calibration, maintenance and qualification of QC equipment and testing systems. You will collaborate with QE/QA engineers to validate processes and drive improvements in testing efficiency and quality.

The role involves maintaining asset records, coordinating calibration services, and ensuring compliance with QMS and regulatory requirements, with opportunities to contribute to

Qualifications

• 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

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.

Skills

Mechanical aptitude

Communication

MS Office

Manufacturing knowledge

Willingness to learn

Education

Nitec or Diploma in Mechanical/Industrial/Manufacturing Engineering or equivalent

Tools

MS Office

Job description

Biosensors Interventional Technologies Pte Ltd in Singapore is seeking a QC Equipment Support Specialist to oversee calibration, maintenance and qualification of QC equipment and testing systems. You will collaborate with QE/QA engineers to validate processes and drive improvements in testing efficiency and quality.

The role involves maintaining asset records, coordinating calibration services, and ensuring compliance with QMS and regulatory requirements, with opportunities to contribute to