Total 36 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

Job Summary:

The Validation Engineer is responsible for ensuring that medical devices and manufacturing processes meet required quality standards and regulatory requirements. It includes lead and/or execute validation activities, including equipment, process, test method and software validation, to ensure that products are manufactured consistently and reliably in accordance with Good Manufacturing Practices (GMP) and other relevant standards.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

Validation Planning and Execution:

• Discuss and develop Master Validation Plan with the engineering / NPI team during the NPI process.
• Develop, implement, and maintain validation protocols and procedures for equipment, processes, and systems in accordance with regulatory requirements and industry best practices.
• Lead the execution of validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and processes.Establish and execute the Test Method Validation.
• Exercise authority to make technical decisions related to validation activities and methodologies.
• Perform risk assessments to identify critical areas and establish validation strategies.
• Ensure the re-validation and periodic review is conducted in a timely manner.

Documentation and Reporting:

• Prepare and review detailed validation documentation, including validation plans, protocols, reports, and change control documents.
• Maintain and update the Master Validation Plan as and when required.
• Authorize and approve validation documents and reports prepared by other team members.
• Maintain accurate and complete records of validation activities and results.

Compliance and Quality Assurance:

• Ensure validation activities comply with FDA regulations, ISO standards (e.g., ISO 13485), and other relevant guidelines.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve validation-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.

Cross-functional Collaboration:

• Collaborate with engineering, manufacturing, and quality assurance teams to ensure seamless integration of validated systems and processes.
• Provide validation expertise and exercise authority in decision-making during the development and implementation of new processes, equipment, and technologies.
• Oversee and support the training of personnel on validation procedures and best practices.

Continuous Improvement:

• Identify opportunities for process improvements and efficiency gains within the validation scope.
• Stay current with industry trends, technological advancements, and regulatory changes related to validation and medical device manufacturing.
• Implement improvements and best practices within the validation framework, with the authority to drive change.

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.

• Ensure kitted jobs release to production are correct such as part numbers and material requirement as stated in the job router.
• Follow and observe proper FIFO (First In First Out) of materials.
• Maintain proper material labelling and stocks recording.
• Ensure actual quantity and ERP system are tally and accurate.
• Ensure kitted jobs and released to production on time.
• Perform material transactions on timely manner.
• Use any safety features (machine guarding, interlocks, etc.) in place at respective machine in use and under any circumstances should not bypass.
• Report immediately to direct supervisor if any safety features (machine guarding, interlocks, etc.) are not functional or present some alteration.
• Perform cut to length process in accordance with the Manufacturing Process Instruction (MPI) and SA0379 document.
• Keep records for the kitted jobs for future reference and easy traceability.
• Perform line clearance and ensure cleanliness of kitting room.
• Maintain and comply with ISO 13485, GMP and FDA regulations.

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.

Job Summary:

The Validation Engineer is responsible for ensuring that medical devices and manufacturing processes meet required quality standards and regulatory requirements. It includes lead and/or execute validation activities, including equipment, process, test method and software validation, to ensure that products are manufactured consistently and reliably in accordance with Good Manufacturing Practices (GMP) and other relevant standards.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

Validation Planning and Execution:

• Discuss and develop Master Validation Plan with the engineering / NPI team during the NPI process.
• Develop, implement, and maintain validation protocols and procedures for equipment, processes, and systems in accordance with regulatory requirements and industry best practices.
• Lead the execution of validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and processes.Establish and execute the Test Method Validation.
• Exercise authority to make technical decisions related to validation activities and methodologies.
• Perform risk assessments to identify critical areas and establish validation strategies.
• Ensure the re-validation and periodic review is conducted in a timely manner.

Documentation and Reporting:

• Prepare and review detailed validation documentation, including validation plans, protocols, reports, and change control documents.
• Maintain and update the Master Validation Plan as and when required.
• Authorize and approve validation documents and reports prepared by other team members.
• Maintain accurate and complete records of validation activities and results.

Compliance and Quality Assurance:

• Ensure validation activities comply with FDA regulations, ISO standards (e.g., ISO 13485), and other relevant guidelines.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve validation-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.

Cross-functional Collaboration:

• Collaborate with engineering, manufacturing, and quality assurance teams to ensure seamless integration of validated systems and processes.
• Provide validation expertise and exercise authority in decision-making during the development and implementation of new processes, equipment, and technologies.
• Oversee and support the training of personnel on validation procedures and best practices.

Continuous Improvement:

• Identify opportunities for process improvements and efficiency gains within the validation scope.
• Stay current with industry trends, technological advancements, and regulatory changes related to validation and medical device manufacturing.
• Implement improvements and best practices within the validation framework, with the authority to drive change.

Essential Duties and Responsibilities:

1. Quality Assurance and Control:

• Develop, implement, and maintain quality assurance plans, procedures, and control measures.
• Monitor and analyse production processes to detect and resolve quality issues.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
• Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
• Participate in new product introductions to ensure quality is built into all products early in their life cycle
• Support validation processes including IQ, OQ, PQ, process validation and test method validation.

2. Process Improvement

• Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
• Lead and drive QA initiatives across the product areas
• Lead or participate in root cause analysis and corrective action planning.
• Support and drive cost improvement project

3. Customer Interaction:

• Address customer complaints and feedback related to product quality.
• Work closely with customers to understand their quality requirements and ensure that products meet their specifications.
• Communicated on any potential change request of the processes to customer.
• Provide technical support and quality-related information to customers.

4. Documentation and Reporting:

• Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
• Prepare and support monthly / annual quality reports to management and other stakeholders.
• Ensure proper documentation and traceability throughout the manufacturing process.

5. Training and Development:

• Train manufacturing staff on quality standards, procedures, and best practices.
• Promote a culture of quality and continuous improvement within the organization.

Education/Experience and Qualifications:

• Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing.
• Diploma holders in Engineering or science with more than 5 years' experience in Quality are welcomed to apply
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.

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:

1. Quality Assurance and Control:

• Develop, implement, and maintain quality assurance plans, procedures, and control measures.
• Monitor and analyse production processes to detect and resolve quality issues.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
• Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
• Participate in new product introductions to ensure quality is built into all products early in their life cycle
• Support validation processes including IQ, OQ, PQ, process validation and test method validation.

2. Process Improvement

• Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
• Lead and drive QA initiatives across the product areas
• Lead or participate in root cause analysis and corrective action planning.
• Support and drive cost improvement project

3. Customer Interaction:

• Address customer complaints and feedback related to product quality.
• Work closely with customers to understand their quality requirements and ensure that products meet their specifications.
• Communicated on any potential change request of the processes to customer.
• Provide technical support and quality-related information to customers.

4. Documentation and Reporting:

• Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
• Prepare and support monthly / annual quality reports to management and other stakeholders.
• Ensure proper documentation and traceability throughout the manufacturing process.

5. Training and Development:

• Train manufacturing staff on quality standards, procedures, and best practices.
• Promote a culture of quality and continuous improvement within the organization.

Education/Experience and Qualifications:

• Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing.
• Diploma holders in Engineering or science with more than 5 years' experience in Quality are welcomed to apply
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.

1. Review and refining existing process flow, and process failure mode and effect analysis (FMEA)
2. Optimizing existing standard operating procedure for quality inspection, cycle time for inspection activities & calibration schedule program.
3. Data trending of quality complains & defect, NC & CAPA through use of SPC.
4. Ad-hoc activities for LHR review and documentation.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Support the implementation of standards and procedures for incoming inspection of materials and components, for in-process assessment of work in progress (WIP), and for final/outgoing inspection & lot release of finished products.
• Perform receiving (incoming) inspection for raw materials and in-process/ outgoing inspection/ lot release of finished products.
• Assist product quality engineer in the investigation and analysis of quality issues.
• Assist product quality engineer in the maintenance of the calibration/ preventive maintenance systems.
• Assist product quality engineer in the qualification/ validation processes and the development of protocols in conjunction with appropriate functions.
• Review and approval of quality records including inspection reports, lot history records.
• Perform testing, and evaluation, which includes sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data.
• Participate in the non-conforming materials review (NCMR) process to ensure that non-conforming products are properly handled.
• Maintain and comply with the requirements of ISO13485, GMP and CFR Part 820 (FDA) regulations.

Education/Experience and Qualifications:

• GCE “O” level or higher, Diploma preferred, with 1~2 years of progressive Quality responsibility preferably in Medical Device Manufacturing.
• Excellent Communication Skills. English written & oral communication skills are a must.
• Computer literate (MS Office).
• Knowledgeable in reading and/ or writing manufacturing procedures and GMP requirements.
• Knowledge of ISO 9001, ISO13485, FDA 21 CFR Part 820, and/ or the Medical Device Directives.
• Willing to work in a multi-cultural team and in a clean room environment.

1. Review and refining existing process flow, and process failure mode and effect analysis (FMEA)
2. Optimizing existing standard operating procedure for quality inspection, cycle time for inspection activities & calibration schedule program.
3. Data trending of quality complains & defect, NC & CAPA through use of SPC.
4. Ad-hoc activities for LHR review and documentation.

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:

The Planner is responsible to ensure the planning for all materials and supplies to meet the operational needs of Quasar Singapore. This position is responsible for developing and maintaining valid production schedules from the demand forecast to meet customer requirements while utilizing resources efficiently. It will require close communications with process engineering, purchasing, production, quality, customers and suppliers.

Essential Duties and Responsibilities:

• Participate in the preparation of the master production schedule, Pack Plan (Short Term) and Long Terms (MPS Plan)
• Review release of Purchase Requisition to buyers for buying.
• Create work orders for production and monitor of work orders to ensure delivery date are met. Size up Materials Clear to build and provide supply commit to Customer Service base on Materials and Capacity.
• Prepare reports and inform management team of scheduling and materials problems as they arise.
• Develop and implement systems that ensure a smooth and reliable flow of materials from vendors through the production cycle.
• Ensure appropriate inventory levels are maintained including the stock room, WIP, and lab supplies.
• KPI includes Revenue, Inventory Days of Supply, Aging Materials Control and Customer OTD.
• Support Monthly report of MOR.
• Support cost reduction initiatives and Assurance of Supply to meet cost and supply need.
• Maintain and comply with ISO 13485, GMP and FDA regulations.

Education/Experience and Qualifications:

• Diploma/Degree in Science or equivalent with 3 years of planning experience in a manufacturing environment, preferably in Medical Device Manufacturing.
• Familiar with LEAN and Six Sigma methodologies
• Working knowledge of ERP systems
• Knowledgeable in writing procedures and GMP requirements
• Knowledge of GMPs, ISO 9001, ISO 13485 and the Medical Device Directives.

Job Summary:

The Validation Engineer is responsible for ensuring that medical devices and manufacturing processes meet required quality standards and regulatory requirements. It includes lead and/or execute validation activities, including equipment, process, test method and software validation, to ensure that products are manufactured consistently and reliably in accordance with Good Manufacturing Practices (GMP) and other relevant standards.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

Validation Planning and Execution:

• Discuss and develop Master Validation Plan with the engineering / NPI team during the NPI process.
• Develop, implement, and maintain validation protocols and procedures for equipment, processes, and systems in accordance with regulatory requirements and industry best practices.
• Lead the execution of validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and processes.Establish and execute the Test Method Validation.
• Exercise authority to make technical decisions related to validation activities and methodologies.
• Perform risk assessments to identify critical areas and establish validation strategies.
• Ensure the re-validation and periodic review is conducted in a timely manner.

Documentation and Reporting:

• Prepare and review detailed validation documentation, including validation plans, protocols, reports, and change control documents.
• Maintain and update the Master Validation Plan as and when required.
• Authorize and approve validation documents and reports prepared by other team members.
• Maintain accurate and complete records of validation activities and results.

Compliance and Quality Assurance:

• Ensure validation activities comply with FDA regulations, ISO standards (e.g., ISO 13485), and other relevant guidelines.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve validation-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.

Cross-functional Collaboration:

• Collaborate with engineering, manufacturing, and quality assurance teams to ensure seamless integration of validated systems and processes.
• Provide validation expertise and exercise authority in decision-making during the development and implementation of new processes, equipment, and technologies.
• Oversee and support the training of personnel on validation procedures and best practices.

Continuous Improvement:

• Identify opportunities for process improvements and efficiency gains within the validation scope.
• Stay current with industry trends, technological advancements, and regulatory changes related to validation and medical device manufacturing.
• Implement improvements and best practices within the validation framework, with the authority to drive change.

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 incumbent is responsible for the receiving, put-away, storage, kitting and shipping processes in accordance with Quasar Singapore’s standard operating procedures.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Responsible for performing incoming receiving, material storage, and ensuring proper handling in accordance with Warehouse SOPs.
• Responsible for issuing materials based on the FIFO method through Work Orders and Inventory Request forms, including cutting materials to specified lengths when necessary.
• Prepare materials for shipping, including the creation of shipping documents and coordination with forwarders for collection according to the agreed shipping dates.
• Ensure compliance with 5S practices and safety requirements.
• Manage the replenishment of packaging materials used in the warehouse.
• Conduct stock-taking activities for raw materials and finished goods.
• Verify that the material systems comply with the guidelines and intent of the Quality Management System.
• Maintain and comply with ISO 13845, GMP and FDA regulations.

Essential Duties and Responsibilities:

1. Quality Assurance and Control:

• Develop, implement, and maintain quality assurance plans, procedures, and control measures.
• Monitor and analyse production processes to detect and resolve quality issues.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
• Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
• Participate in new product introductions to ensure quality is built into all products early in their life cycle
• Support validation processes including IQ, OQ, PQ, process validation and test method validation.

2. Process Improvement

• Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
• Lead and drive QA initiatives across the product areas
• Lead or participate in root cause analysis and corrective action planning.
• Support and drive cost improvement project

3. Customer Interaction:

• Address customer complaints and feedback related to product quality.
• Work closely with customers to understand their quality requirements and ensure that products meet their specifications.
• Communicated on any potential change request of the processes to customer.
• Provide technical support and quality-related information to customers.

4. Documentation and Reporting:

• Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
• Prepare and support monthly / annual quality reports to management and other stakeholders.
• Ensure proper documentation and traceability throughout the manufacturing process.

5. Training and Development:

• Train manufacturing staff on quality standards, procedures, and best practices.
• Promote a culture of quality and continuous improvement within the organization.

Education/Experience and Qualifications:

• Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing.
• Diploma holders in Engineering or science with more than 5 years' experience in Quality are welcomed to apply
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.

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:

The BOM (Bill of Materials) Specialist is mainly responsible for leading the creation, maintenance, and management of accurate and comprehensive Bills of Materials and router within the company’s ERP system. This role is crucial for ensuring the integrity of product configuration data, supporting production planning, material procurement, and overall supply chain efficiency.

Essential Duties and Responsibilities:

• Include the following. Other duties may be assigned.
• Lead the creation, updating, and maintenance of parts, BOMs within the ERP system, ensuring data accuracy and completeness.
• Collaborate with engineering, production, and procurement teams to gather, verify, and implement product structure and component information.
• Manage the implementation of engineering change orders (ECOs) into BOMs, aligning them with production requirements.
• Ensure that BOM data supports material requirement planning (MRP), inventory control, and procurement processes.
• Identify, analyse, and resolve BOM discrepancies in collaboration with cross-functional teams.
• Mentor and support junior staff in BOMand router management and best practices.
• Drive continuous improvement initiatives in BOM, router or etcmanagement and configuration data processes.
• Develop and analyse BOM-related reports to support strategic decision-making.
• Support engineers on documents help request with cross function team work, such as initiate and follow up different kinds of forms, follow up change plan progress etc.
• Support engineering manager on administrative tasks for whole engineering department.
• Support engineering manager to manage ECO change plan progress summary for KPI and MOR report. Push related engineers to close change plans within KPIs.
• Ensure compliance with company policies, industry standards, and regulatory requirements in BOM management.
• Any other tasks assigned from supervisor.

Authority:

• The BOM Specialist has the authority to approve BOM updates and changes, including the implementation of engineering change orders (ECOs) into the system, which aligned with engineer’s requirement.
• This position also has the authority to recommend process improvements and lead initiatives within the BOM management function.
• While the BOM Specialist does not have direct reports, they have the authority to mentor and guide junior team members, providing training and oversight as needed

Education/Experience and Qualifications:

• Bachelor's degree in Engineering, Supply Chain Management, or a related field.
• 3-5 years of experience in BOM management or a related role in a manufacturing environment.
• Strong expertise in ERP systems and BOM management processes.
• Proven ability to work effectively in cross-functional teams and lead initiatives.
• Advanced proficiency in ERP systems, particularly in BOM management modules; strong Microsoft Excel skills, including the ability to use advanced functions and pivot tables.
• In-depth understanding of product lifecycle management (PLM), manufacturing processes, inventory management, and engineering documentation.
• Strong analytical skills with the ability to troubleshoot issues, interpret complex data, and generate actionable insights.
• Excellent verbal and written communication skills, with the ability to effectively convey technical information to non-technical stakeholders.
• Ability to lead projects, mentor junior team members, and drive process improvements.
• Exceptional attention to detail, ensuring the highest levels of accuracy in all work.

1. Review and refining existing process flow, and process failure mode and effect analysis (FMEA)
2. Optimizing existing standard operating procedure for quality inspection, cycle time for inspection activities & calibration schedule program.
3. Data trending of quality complains & defect, NC & CAPA through use of SPC.
4. Ad-hoc activities for LHR review and documentation.