- Singapore Singapore
Full Time Assistant QA Engineer Jobs, Salary up to SGD 3,800 in Biosensors International - Maukerja
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Job Description
Responsibilities
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
For more than 25 years, the Biosensors International Group (“Biosensors”) has been developing and marketing critical care catheter systems and related devices used during heart surgery and intensive care treatment.
Continually striving to be at the forefront of product innovation, with a focus on improving patient outcomes today, we are driving the development of tomorrow’s next generation medical technology.
In the year 2000 we entered the interventional cardiology market and immediately became the first cardiology company to develop and patent their own proprietary limus agent, Biolimus A9 (BA9), a highly lipophilic1 anti-restenotic drug designed for cardiovascular stent technologies.
We were also the first stent company to develop and launch a biodegradable polymer stent with only the abluminal side coated with polymer and drug to reduce systemic exposure.
Over the last two-decades Biosensors has become one of the largest manufacturers and suppliers of cardiovascular stents globally.
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
For more than 25 years, the Biosensors International Group (“Biosensors”) has been developing and marketing critical care catheter systems and related devices used during heart surgery and intensive care treatment.
Continually striving to be at the forefront of product innovation, with a focus on improving patient outcomes today, we are driving the development of tomorrow’s next generation medical technology.
In the year 2000 we entered the interventional cardiology market and immediately became the first cardiology company to develop and patent their own proprietary limus agent, Biolimus A9 (BA9), a highly lipophilic1 anti-restenotic drug designed for cardiovascular stent technologies.
We were also the first stent company to develop and launch a biodegradable polymer stent with only the abluminal side coated with polymer and drug to reduce systemic exposure.
Over the last two-decades Biosensors has become one of the largest manufacturers and suppliers of cardiovascular stents globally.
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