Total 37 job vacancies by Quasar Medical (singapore) Pte. Ltd.

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

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.

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:

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