Total 14 job vacancies by Quasar Medical (singapore) Pte. Ltd.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.

• Train and supervise assemblers and Team Leaders. Motivate, coach, and support the team in meeting the expectations
• Participate and encourage the team to support company activities and program
• Support the business as necessary, across other lines when required. Focus on teamwork.
• Proposing solutions to routine issues/ problems following standard policies and procedures.
• Drive and implement safety initiatives, support training for EH&S activities
• Drive safety in a working place. Responsible for Health & Safety within assigned areas to include accident investigation and corrective action. Closing of Velocity within the timeframe.
• Ensure compliance to the training plans in accordance with SOP0014, procedures, and industry regulations.
• Provide day-to-day direction to the production personnel concerning work assignments, overtime requirements, quality issues/non-conformances, and site priorities.
• Review the master schedule, Open Sales Order Report and work closely with Supply Chain to meet STS/STR target
• Drive compliance to standard operating procedures and quality regulations.
• Initiate and closing of Change Plan/ NC in accordance with company requirements.
• Drive department performance to meet Production KPI’s may include but not limited to Materials Accuracy, Yield, Efficiency and Productivity.
• Participate and work closely with Support group in developing new procedures and processes as needed to improve manufacturing processes for new products.
• Work with Support group for process refinements to improve product throughput, design of fixtures and assembly techniques.
• Coordinate with support group and initiate ECO to change and improve manufacturing processes if needed
• Procure and oversee outside vendors and consultants as required.
• Drive and maintain 5S in working place
• Maintain and comply with ISO13485, GMP and FDA regulations.
• Support site process improvement projects and initiatives. Process improvements may include but are not limited to Lean, Six Sigma, 5S, and cost reduction/savings.

SUPERVISORY RESPONSIBILITIES:

• Ensure workers under their charge comply with Safe Work Procedure, Risk Assessment and safety rules & regulations.
• Provide proper tools for the workers to execute job effectively and safely.
• Train and guide workers to work safely.
• Report all unsafe conditions, incident and near miss to direct Manager
• Set good example for workers and be a role model for workers.
• Conduct regular inspection at the workplace to identify and rectify any unsafe act or unsafe condition at the workplace

Key Responsibilities:

• Assist in evaluating manufacturing processes by supporting research programs, applying knowledge of product design and materials, and collaborating with operators and vendors.
• Help design and develop manufacturing processes for new products and enhancements, including related tooling and fixtures.
• Support process troubleshooting and refinements to improve product throughput and assembly techniques.
• Contribute to improving manufacturing efficiency by analyzing workflow, space requirements, and equipment layout.
• Participate in process qualifications and validations, including equipment qualifications and material specifications.
• Assist in ensuring product and process quality by supporting the design of testing methods and confirming manufacturing processes.
• Provide manufacturing decision-making information by assisting in calculations of production, labor, and material costs, and reviewing production schedules.
• Help prepare product and process reports by collecting, analyzing, and summarizing information and trends.
• Assist in keeping equipment operational by coordinating maintenance and repair services, following manufacturer’s instructions and procedures.
• Support Health & Safety initiatives in assigned areas, including accident investigation and corrective actions.
• Research state-of-the-art process technologies and evaluate their potential benefits.
• Participate in Validation Activities as directed.
• Assist in maintaining compliance with ISO 13485, GMP, and FDA regulations.

Education/Experience and Qualifications:

• Bachelor’s degree in Engineering or a similar technical field.
• Up to 2 years of experience in a high-volume production environment; experience in medical device manufacturing, particularly catheter production, is a plus.
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Basic understanding of DOE and statistical techniques.
• Familiarity with process capabilities and control charting is preferred.
• Exposure to writing protocols for validations and qualifications, including FMEA and IQ/OQ documentation.
• Awareness of GMPs, ISO 9001, ISO 13485, and Medical Device Directives.
• Self-motivated and eager to drive change and innovation. Must be comfortable working in a fast-paced environment with minimal supervision.

Job Summary:

Ensure production line produce top quality products and delivery on time, ensure operation normally.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Monitor the production safety and discipline of production area. Involve and support Health and Safety programs (DWB, BBS, H&S meetings).
• Monitor operator’s daily work in workshop; Manage the discipline and 6S in production section.
• Arrange the production according to production plan, and monitor the progress.
• Drive department performance to meet Production KPI’s may include but not limited to Materials Accuracy, Yield, Efficiency and Productivity.
• Troubleshooting and promptly feedback to superior.
• Coordinate with other departments to analyze the root cause of defective products, and take corrective and preventive action to avoid the same problem happen repeatedly.
• Responsible for the allocation of resource for production lines, including manpower, equipment, materials
• Monitor’s records/ database and document management in production line integrity, accuracy and effectiveness.
• Propose kaizen suggestions, optimize production line, promote efficiency, and reduce scrap and costs.
• Deal with other assignments assigned by superior.
• Supervise assemblers and Team Leaders. Motivate, coach, and support the team in meeting the expectations
• Participate and encourage the team to support company activities and program

Key Responsibilities:

• Assist in evaluating manufacturing processes by supporting research programs, applying knowledge of product design and materials, and collaborating with operators and vendors.
• Help design and develop manufacturing processes for new products and enhancements, including related tooling and fixtures.
• Support process troubleshooting and refinements to improve product throughput and assembly techniques.
• Contribute to improving manufacturing efficiency by analyzing workflow, space requirements, and equipment layout.
• Participate in process qualifications and validations, including equipment qualifications and material specifications.
• Assist in ensuring product and process quality by supporting the design of testing methods and confirming manufacturing processes.
• Provide manufacturing decision-making information by assisting in calculations of production, labor, and material costs, and reviewing production schedules.
• Help prepare product and process reports by collecting, analyzing, and summarizing information and trends.
• Assist in keeping equipment operational by coordinating maintenance and repair services, following manufacturer’s instructions and procedures.
• Support Health & Safety initiatives in assigned areas, including accident investigation and corrective actions.
• Research state-of-the-art process technologies and evaluate their potential benefits.
• Participate in Validation Activities as directed.
• Assist in maintaining compliance with ISO 13485, GMP, and FDA regulations.

Education/Experience and Qualifications:

• Bachelor’s degree in Engineering or a similar technical field.
• Up to 2 years of experience in a high-volume production environment; experience in medical device manufacturing, particularly catheter production, is a plus.
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Basic understanding of DOE and statistical techniques.
• Familiarity with process capabilities and control charting is preferred.
• Exposure to writing protocols for validations and qualifications, including FMEA and IQ/OQ documentation.
• Awareness of GMPs, ISO 9001, ISO 13485, and Medical Device Directives.
• Self-motivated and eager to drive change and innovation. Must be comfortable working in a fast-paced environment with minimal supervision.

Job Summary:

The Production Manager is responsible for managing all aspects of production operations, ensuring that production processes are compliant with company policies, safety requirements, quality requirements, and regulatory requirements. This role involves leading production teams, managing production plans, and promoting production efficiency and continuous improvement. The Production Manager will oversee the Production team and provide strategic direction and leadership to the entire production department.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Oversee the entire production operation to ensure compliance with company policies and regulatory requirements.
• Develop and implement production strategies to achieve company objectives and production targets.
• Review production orders and plans to ensure qualified products are produced within schedule.
• Lead teams to analyze production variances and take effective corrective actions.
• Push for equipment management and maintenance to support production plans.
• Promote lean manufacturing and continuous improvement initiatives using VSM, cell line, and other lean tools.
• Monitor quality checks and resolve production quality issues, ensuring compliance with ISO13485, ISO9001, and FDA regulations. Lead FDA inspection and external audits related to production ownership areas with 0 audit findings goal.
• Manage labor and maintain a safe and efficient work environment, leading 5S and EHS activities in the production department.
• Train and motivate production teams, ensuring timely completion of work and continuous skill development.
• Participate in management reviews and coordinate with other departments to achieve production goals.
• Drive department performance through production and quality metrics such as output yield (FPY, FY), production schedule OTD, daily fill rates, and cost control.
• Ensure effective resource allocation, including labor, materials, and equipment.
• Support process refinements, qualifications, and validations, including equipment and material specifications.
• Ensure complete and accurate documentation of production processes.
• Ensure all procedures under production ownership are effective and efficient, making sure actual practices follow documents with zero gaps.
• Conduct regular workplace inspections to identify and rectify unsafe conditions.
• Oversee health and safety within the production department, including accident investigation and corrective actions.
• Ensure environmental aspect and safety hazard risk assessments are conducted and controlled.
• Report all occupational accidents and incidents immediately and support EHS Committee Management Representative in investigations.
• Enforce compliance with EHS management systems and relevant legal and other applicable EHS requirements.
• Provide leadership and direction in EHS internal and external audits.
• Coordinate and communicate with other departments to support production goals.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Involve and support Health and Safety programs (DWB, BBS, H&S meetings).
• Responsible for Induction and Good Manufacturing Practices Training to new operators.
• Perform 24 months recertification for operators.
• Conduct quarterly GMP meeting for operators, review and help the team to address issues
• Ensure the completeness of Certification, Recertification and Retraining requirements
• Design and update On the Job Training Assessment & training material.
• Design new & update existing evaluation form and exam paper.
• Responsible in Preparing and updating operator Training Matrix chart.
• Assist in keeping and maintaining operators training record.
• Involve and support in Production/ Engineering Improvement Project (Kaizen).
• Support projects in Talent Development as assigned. Examples – Video-editing, E-assessment project, Improvement on production training
• Develop and conduct Core training program to equip Production Operators with skills and knowledge to perform the task in the production.
• Initiate, lead and participate in training-related projects.
• Maintain and comply with ISO13485, GMP and FDA regulations.

Education/Experience and Qualifications:

• GCE “O” level or higher with 3–5-year assembly experience preferably in medical device.
• Knowledgeable in writing manufacturing procedures and GMP requirements.
• Knowledgeable in GMP, ISO, cleanroom procedures, and documentation
• Good technical knowledge and understanding of broad scope of manufacturing processes.
• Computer literacy required. Familiar with Microsoft office applications.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• Design and develop manufacturing processes for new products, product changes and enhancements, as well as related tooling and fixtures.
• Process troubleshooting, refinements to improve product throughput, design of fixtures and assembly techniques.
• Improves manufacturing efficiency by analysing and planning work flow, space requirements, and equipment layout.
• Process qualifications and validations including equipment qualifications and material specifications.
• Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
• Provides manufacturing decision-making information by calculating production, labour, and material costs; reviewing production schedules; estimating future requirements.
• Prepares product and process reports by collecting, analysing, and summarizing information and trends.
• Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
• Responsible for Health & Safety within assigned areas to include accident investigation and corrective action.
• Investigate state-of-the-art process technologies and evaluate potential competitive advantage and the cost benefit of introduction.
• Oversee and drive Validation Activities.
• Maintain and comply with ISO13485, GMP and FDA regulations.

Education/Experience and Qualifications:

• Availability to travel to sending site for duration of onsite training
• Bachelor in Engineering or similar technical field with 5 to 8 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Proficient in DOE and statistical techniques.
• Knowledgeable in defining process capabilities and control charting.
• Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives
• Self-motivated and driver of change and innovation. Must be willing to work in a fast-paced environment with minimum supervision.

Job Summary:

Assignments are done with minimal supervision. In this position, the Production Trainer is skilled in the functions related to basic manufacturing activities and responsible for training manufacturing process, SOP’s and other related documents for existing employees and new Assembly Operators.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Involve and support Health and Safety programs (DWB, BBS, H&S meetings).
• Responsible for Induction and Good Manufacturing Practices Training to new operators.
• Perform 24 months recertification for operators.
• Conduct quarterly GMP meeting for operators, review and help the team to address issues
• Ensure the completeness of Certification, Recertification and Retraining requirements
• Design and update On the Job Training Assessment & training material.
• Design new & update existing evaluation form and exam paper.
• Responsible in Preparing and updating operator Training Matrix chart.
• Assist in keeping and maintaining operators training record.
• Involve and support in Production/ Engineering Improvement Project (Kaizen).
• Support projects in Talent Development as assigned. Examples – Video-editing, E-assessment project, Improvement on production training
• Develop and conduct Core training program to equip Production Operators with skills and knowledge to perform the task in the production.
• Initiate, lead and participate in training-related projects.
• Maintain and comply with ISO13485, GMP and FDA regulations.

Education/Experience and Qualifications:

• GCE “O” level or higher with 3–5-year assembly experience preferably in medical device.
• Knowledgeable in writing manufacturing procedures and GMP requirements.
• Knowledgeable in GMP, ISO, cleanroom procedures, and documentation
• Good technical knowledge and understanding of broad scope of manufacturing processes.
• Computer literacy required. Familiar with Microsoft office applications.

Job Summary:

Ensure production line produce top quality products and delivery on time, ensure operation normally.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Monitor the production safety and discipline of production area. Involve and support Health and Safety programs (DWB, BBS, H&S meetings).
• Monitor operator’s daily work in workshop; Manage the discipline and 6S in production section.
• Arrange the production according to production plan, and monitor the progress.
• Drive department performance to meet Production KPI’s may include but not limited to Materials Accuracy, Yield, Efficiency and Productivity.
• Troubleshooting and promptly feedback to superior.
• Coordinate with other departments to analyze the root cause of defective products, and take corrective and preventive action to avoid the same problem happen repeatedly.
• Responsible for the allocation of resource for production lines, including manpower, equipment, materials
• Monitor’s records/ database and document management in production line integrity, accuracy and effectiveness.
• Propose kaizen suggestions, optimize production line, promote efficiency, and reduce scrap and costs.
• Deal with other assignments assigned by superior.
• Supervise assemblers and Team Leaders. Motivate, coach, and support the team in meeting the expectations
• Participate and encourage the team to support company activities and program

Job Summary:

Comply with the management regulation of company and department, working according to MPI’s, QI’s and other WI’s strictly.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Responsible for the safe operations of equipment to manufacture products. Perform checks and ensure safety features (machine guarding, interlocks, etc) is in place and under any circumstances should not bypass.
• Maintain 6S in working area. Follow standard
• Report immediately to direct supervisor if any safety features (machine guarding, interlocks, etc) are not functional or present some alteration.
• Comply with the management regulation of company and department, obey the job assignment.
• Operation must be conducted according to WI strictly，and familiar with their related responsibility
• Deal with other assignments assigned by superior.

Job Summary:

The scope of this role is to support the Balloon Catheter line or Extrusion, Braid and Shaft Coil line in Singapore. Develop, improve manufacturing processes by studying product and manufacturing methods in all areas of the Quasar Singapore.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• Design and develop manufacturing processes for new products, product changes and enhancements, as well as related tooling and fixtures.
• Process troubleshooting, refinements to improve product throughput, design of fixtures and assembly techniques.
• Improves manufacturing efficiency by analysing and planning work flow, space requirements, and equipment layout.
• Process qualifications and validations including equipment qualifications and material specifications.
• Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
• Provides manufacturing decision-making information by calculating production, labour, and material costs; reviewing production schedules; estimating future requirements.
• Prepares product and process reports by collecting, analysing, and summarizing information and trends.
• Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
• Responsible for Health & Safety within assigned areas to include accident investigation and corrective action.
• Investigate state-of-the-art process technologies and evaluate potential competitive advantage and the cost benefit of introduction.
• Oversee and drive Validation Activities.
• Maintain and comply with ISO13485, GMP and FDA regulations.

Education/Experience and Qualifications:

• Availability to travel to sending site for duration of onsite training
• Bachelor in Engineering or similar technical field with 5 to 8 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Proficient in DOE and statistical techniques.
• Knowledgeable in defining process capabilities and control charting.
• Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives
• Self-motivated and driver of change and innovation. Must be willing to work in a fast-paced environment with minimum supervision.

Job Summary:

Ensure production line produce top quality products and delivery on time, ensure operation normally.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Monitor the production safety and discipline of production area. Involve and support Health and Safety programs (DWB, BBS, H&S meetings).
• Monitor operator’s daily work in workshop; Manage the discipline and 6S in production section.
• Arrange the production according to production plan, and monitor the progress.
• Drive department performance to meet Production KPI’s may include but not limited to Materials Accuracy, Yield, Efficiency and Productivity.
• Troubleshooting and promptly feedback to superior.
• Coordinate with other departments to analyze the root cause of defective products, and take corrective and preventive action to avoid the same problem happen repeatedly.
• Responsible for the allocation of resource for production lines, including manpower, equipment, materials
• Monitor’s records/ database and document management in production line integrity, accuracy and effectiveness.
• Propose kaizen suggestions, optimize production line, promote efficiency, and reduce scrap and costs.
• Deal with other assignments assigned by superior.
• Supervise assemblers and Team Leaders. Motivate, coach, and support the team in meeting the expectations
• Participate and encourage the team to support company activities and program

Job Summary:

Comply with the management regulation of company and department, working according to MPI’s, QI’s and other WI’s strictly.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Responsible for the safe operations of equipment to manufacture products. Perform checks and ensure safety features (machine guarding, interlocks, etc) is in place and under any circumstances should not bypass.
• Maintain 6S in working area. Follow standard
• Report immediately to direct supervisor if any safety features (machine guarding, interlocks, etc) are not functional or present some alteration.
• Comply with the management regulation of company and department, obey the job assignment.
• Operation must be conducted according to WI strictly，and familiar with their related responsibility
• Deal with other assignments assigned by superior.

Job Summary:

The scope of this role is to support the Balloon Catheter line or Extrusion, Braid and Shaft Coil line in Singapore. Develop, improve manufacturing processes by studying product and manufacturing methods in all areas of the Quasar Singapore.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• Design and develop manufacturing processes for new products, product changes and enhancements, as well as related tooling and fixtures.
• Process troubleshooting, refinements to improve product throughput, design of fixtures and assembly techniques.
• Improves manufacturing efficiency by analysing and planning work flow, space requirements, and equipment layout.
• Process qualifications and validations including equipment qualifications and material specifications.
• Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
• Provides manufacturing decision-making information by calculating production, labour, and material costs; reviewing production schedules; estimating future requirements.
• Prepares product and process reports by collecting, analysing, and summarizing information and trends.
• Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
• Responsible for Health & Safety within assigned areas to include accident investigation and corrective action.
• Investigate state-of-the-art process technologies and evaluate potential competitive advantage and the cost benefit of introduction.
• Oversee and drive Validation Activities.
• Maintain and comply with ISO13485, GMP and FDA regulations.

Education/Experience and Qualifications:

• Availability to travel to sending site for duration of onsite training
• Bachelor in Engineering or similar technical field with 5 to 8 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Proficient in DOE and statistical techniques.
• Knowledgeable in defining process capabilities and control charting.
• Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives
• Self-motivated and driver of change and innovation.
• Must be willing to work in a fast-paced environment with minimum supervision.