1,396 Qm Specialist jobs in Singapore

• Ensure the establishment and maintenance of SAP's QMS to the latest ISO 13485 QMS, FSCA/FCA and CSV-equivalent requirements.
• Develop and execute quality strategies to enhance the company efficiency and effectiveness pertaining FCA/FSCA, product recall and CSV/SDLC.
• Initiate, lead and monitor the execution FCA, Recall & FSCA, AE, and other postmarket surveillance related activities with customer care and any other relevant departments within Sysmex AP affiliates and business partners and manufacturers.
• Manage the business change control and quality impact pertaining to FSCA/FCA and CSV related activities at SAP and provide guidance and support to affiliates. Work with affiliates process owner(s) to ensure the initiation and implementation of post-market activities are in accordance with regional and site procedures. Facilitate a continuous improvement culture in Post-market activities within SAP and extends to affiliates QA.
• Perform and lead computer system validation activities related to authoring and executing specifications and validation documentation for process and systems according to the GAMP5 Validation Life Cycle related to software development/testing life cycle.
• Review and support the execution of Computer System Validation and ensure compliance, adherence with corporate guidelines procedures, CGMP and GAMP guidelines and regulations.
• Mentor affiliates CSV leads in their validation activities to be in compliance with the related regulations, procedures and local requirements.
• Support the establishment and implementation of ISO27001: 2022, jointly with QM Manager. Support appointed Project Manager and QM Manager to attain ISO27001 certification.
• Getting the organization ready for ISO27001: 2022 should there be any scope expansion. Jointly with QM Manager, execute the maintenance of ISO27001 QMS accordingly.
• Support Corporate Auditors on CSV or software related validation associated with infrastructure and non-product related.
• Execute any tasks given by supervisor or SAP's management.

• Bachelor's Degree in Engineering or Science
• 5 years of Quality Management experience in Medical Device industry.
• 3 years of CSV documentation & processes validation.
• Lead auditor certification to ISO 13485:2016, ISO 9001: 2015, ISO 27001: 2022.
• Well-versed in QMS and SDLC, ERP (21 CFR Parts 11, 210 and 820).
• Good understanding of computer systems / software used in various companies in the medical industry.

Key Job Purpose:

• Manage Post Market Surveillance activities (FCA, Recall, FSCA, AE) in the APAC region, ensuring compliance with laws, regulations, and quality standards.
• Support QMS audits in APAC (ISO 9001, 13485, 14001) related to FSCA/FCA compliance.
• Oversee QM/QA aspects in design changes, change requests, and CSV (Computer System Validation) documentation for software and hardware.
• Ensure CSV processes comply with company QMS, cGMP, GAMP, ER/ES, and other relevant standards/regulations.
• Act as Regional Subject Matter Expert (SME) for post-market activities and CSV; provide guidance to affiliates.
• Serve as QM representative in ISO 27001:2022 Information Security Management System (ISMS) project:
  
  Support implementation and certification efforts.
  
  Assist in scope expansion based on business direction.
  
  Maintain ongoing ISO 27001:2022 compliance.

Job Description:

• Ensure the establishment and maintenance of SAP's QMS to the latest ISO 13485 QMS, FSCA/FCA and CSV-equivalent requirements.
• Develop and execute quality strategies to enhance the company efficiency and effectiveness pertaining FCA/FSCA, product recall and CSV/SDLC.
• Initiate, lead and monitor the execution FCA, Recall & FSCA, AE, and other postmarket surveillance related activities with customer care and any other relevant departments within organization affiliates and business partners and manufacturers.
• Manage the business change control and quality impact pertaining to FSCA/FCA and CSV related activities at SAP and provide guidance and support to affiliates. Work with affiliates process owner(s) to ensure the initiation and implementation of post-market activities are in accordance with regional and site procedures. Facilitate a continuous improvement culture in Post-market activities within SAP and extends to affiliates QA.
• Perform and lead computer system validation activities related to authoring and executing specifications and validation documentation for process and systems according to the GAMP5 Validation Life Cycle related to software development/testing life cycle.
• Review and support the execution of Computer System Validation and ensure compliance, adherence with corporate guidelines procedures, CGMP and GAMP guidelines and regulations.
• Mentor affiliates CSV leads in their validation activities to be in compliance with the related regulations, procedures and local requirements.
• Support the establishment and implementation of ISO27001: 2022, jointly with QM Manager. Support appointed Project Manager and QM Manager to attain ISO27001 certification.
• Getting the organization ready for ISO27001: 2022 should there be any scope expansion. Jointly with QM Manager, execute the maintenance of ISO27001 QMS accordingly.
• Support Corporate Auditors on CSV or software related validation associated with infrastructure and non-product related.
• Execute any tasks given by supervisor or SAP's management.

Job Requirements :

• Bachelor's Degree in Engineering or Science
• 5 years of Quality Management experience in Medical Device industry.
• 3 years of CSV documentation & processes validation.
• Lead auditor certification to ISO 13485:2016, ISO 9001: 2015, ISO 27001: 2022.
• Well-versed in QMS and SDLC, ERP (21 CFR Parts 11, 210 and 820).
• Good understanding of computer systems / software used in various companies in the medical industry.

HOW TO APPLY

Interested applicants, kindly click on "APPLY NOW" or send your resume in MS WORD format to hestia.wong(at)trustrecruit.com.sg

We regret only shortlisted candidates will be notified.

Important Note: Trust Recruit Pte Ltd is committed to safeguarding your personal data in accordance with the Personal Data Protection Act (PDPA).

Please read our privacy statement on our corporate website

Trust Recruit Pte Ltd

EA License No: 19C9950

EA Personnel: Wong Ying Huan (Hestia)

EA Personnel Reg No: R

Key Job Purpose:

Manage the Post Market Surveillance management (FCA, Recall & FSCA, AE), and other QM related matters in AP region to comply with the law, regulations and requirementas well as keep enhancing quality level of management and products. Support all QMS audits in accordance to ISO 9001, 13485 & 14001 in the AP territory with respect to FSCA/FCA.

Manage the QM/QA aspects in review, design change, Change Request and finalisation of the CSV related documentation for SW and hardware. Ensure all CSV processes and documentation is in full compliance with the Sysmex QMS, all relevant standards (cGMP, GAMP, ER/ES) and other related standards and regulations. As RHQ Subject Matter Expert (SME) for post-market activities and CSV, shall provide regional guidance and support to all Affiliates on these assigned aspects.

QM representative in ISO27001:2022 Information Security Management System (ISMS) project and support the Project Manager in establishing and implementing ISO27001 and attaining certification per project plan. Support the scope expansion of ISO27001:2022 per business direction. Compliance maintenance to ISO27001:2022 subsequently.

Job Description:

• Ensure the establishment and maintenance of SAP's QMS to the latest ISO 13485 QMS, FSCA/FCA and CSV-equivalent requirements.
• Develop and execute quality strategies to enhance the company efficiency and effectiveness pertaining FCA/FSCA, product recall and CSV/SDLC.
• Initiate, lead and monitor the execution FCA, Recall & FSCA, AE, and other postmarket surveillance related activities with customer care and any other relevant departments within Sysmex AP affiliates and business partners and manufacturers.
• Manage the business change control and quality impact pertaining to FSCA/FCA and CSV related activities at SAP and provide guidance and support to affiliates. Work with affiliates process owner(s) to ensure the initiation and implementation of post-market activities are in accordance with regional and site procedures. Facilitate a continuous improvement culture in Post-market activities within SAP and extends to affiliates QA.
• Perform and lead computer system validation activities related to authoring and executing specifications and validation documentation for process and systems according to the GAMP5 Validation Life Cycle related to software development/testing life cycle.
• Review and support the execution of Computer System Validation and ensure compliance, adherence with corporate guidelines procedures, CGMP and GAMP guidelines and regulations.
• Mentor affiliates CSV leads in their validation activities to be in compliance with the related regulations, procedures and local requirements.
• Support the establishment and implementation of ISO27001: 2022, jointly with QM Manager. Support appointed Project Manager and QM Manager to attain ISO27001 certification.
• Getting the organization ready for ISO27001: 2022 should there be any scope expansion. Jointly with QM Manager, execute the maintenance of ISO27001 QMS accordingly.
• Support Corporate Auditors on CSV or software related validation associated with infrastructure and non-product related.
• Execute any tasks given by supervisor or SAP's management.

Job Requirements :

• Bachelor's Degree in Engineering or Science
• 5 years of Quality Management experience in Medical Device industry.
• 3 years of CSV documentation & processes validation.
• Lead auditor certification to ISO 13485:2016, ISO 9001: 2015, ISO 27001: 2022.
• Well-versed in QMS and SDLC, ERP (21 CFR Parts 11, 210 and 820).
• Good understanding of computer systems / software used in various companies in the medical industry.

Key Job Purpose:

Manage the Post Market Surveillance management (FCA, Recall & FSCA, AE), and other QM related matters in AP region to comply with the law, regulations and requirementas well as keep enhancing quality level of management and products. Support all QMS audits in accordance to ISO 9001, 13485 & 14001 in the AP territory with respect to FSCA/FCA.

Manage the QM/QA aspects in review, design change, Change Request and finalisation of the CSV related documentation for SW and hardware. Ensure all CSV processes and documentation is in full compliance with the Sysmex QMS, all relevant standards (cGMP, GAMP, ER/ES) and other related standards and regulations. As RHQ Subject Matter Expert (SME) for post-market activities and CSV, shall provide regional guidance and support to all Affiliates on these assigned aspects.

QM representative in ISO27001:2022 Information Security Management System (ISMS) project and support the Project Manager in establishing and implementing ISO27001 and attaining certification per project plan. Support the scope expansion of ISO27001:2022 per business direction. Compliance maintenance to ISO27001:2022 subsequently.

Job Description:

• Ensure the establishment and maintenance of SAP’s QMS to the latest ISO 13485 QMS, FSCA/FCA and CSV-equivalent requirements.
• Develop and execute quality strategies to enhance the company efficiency and effectiveness pertaining FCA/FSCA, product recall and CSV/SDLC.
• Initiate, lead and monitor the execution FCA, Recall & FSCA, AE, and other postmarket surveillance related activities with customer care and any other relevant departments within Sysmex AP affiliates and business partners and manufacturers.
• Manage the business change control and quality impact pertaining to FSCA/FCA and CSV related activities at SAP and provide guidance and support to affiliates. Work with affiliates process owner(s) to ensure the initiation and implementation of post-market activities are in accordance with regional and site procedures. Facilitate a continuous improvement culture in Post-market activities within SAP and extends to affiliates QA.
• Perform and lead computer system validation activities related to authoring and executing specifications and validation documentation for process and systems according to the GAMP5 Validation Life Cycle related to software development/testing life cycle.
• Review and support the execution of Computer System Validation and ensure compliance, adherence with corporate guidelines procedures, CGMP and GAMP guidelines and regulations.
• Mentor affiliates CSV leads in their validation activities to be in compliance with the related regulations, procedures and local requirements.
• Support the establishment and implementation of ISO27001: 2022, jointly with QM Manager. Support appointed Project Manager and QM Manager to attain ISO27001 certification.
• Getting the organization ready for ISO27001: 2022 should there be any scope expansion. Jointly with QM Manager, execute the maintenance of ISO27001 QMS accordingly.
• Support Corporate Auditors on CSV or software related validation associated with infrastructure and non-product related.
• Execute any tasks given by supervisor or SAP’s management.

Job Requirements :

• Bachelor’s Degree in Engineering or Science
• 5 years of Quality Management experience in Medical Device industry.
• 3 years of CSV documentation & processes validation.
• Lead auditor certification to ISO 13485:2016, ISO 9001: 2015, ISO 27001: 2022.
• Well-versed in QMS and SDLC, ERP (21 CFR Parts 11, 210 and 820).
• Good understanding of computer systems / software used in various companies in the medical industry.

WE TAKE YOU ABOVE BEYOND

Take your passion to the next level and work alongside other masters of their craft to build a fulfilling and rewarding career at Marina Bay Sands.

Job Responsibilities

• Process Analysis and Improvement:
• Assist in the analysis of current operational processes to identify inefficiencies and areas for improvement.
• Utilize principles of Lean, Kaizen 5S, and other process improvement methodologies to drive efficiency.
• Resource Optimization:
• Assist in monitoring resource allocation using data to ensure optimal utilization.
• Assist in implementing best practices for resource management to reduce waste and improve productivity.
• Inventory Management:
• Assist in monitoring inventory levels to ensure optimal stock levels and minimize excess inventory.
• Assist in implementing inventory control procedures to improve accuracy and reduce discrepancies.
• Assist in regular inventory audits.
• Data Analysis and Reporting:
• Assist in collecting and organizing data to measure the effectiveness of process improvements.
• Assist in preparing reports and presentations on operational performance and improvement outcomes.
• Compliance and Quality Assurance:
• Ensure that all operational processes comply with legal regulations and industry standards.
• Implement quality control measures to maintain high standards of operational performance

Job Requirements

Education & Certification

• Applicant must be a full-time matriculated student.
• Internship must contribute to school graduation requirements.

Experience

• No experience required as training will be provided

Other Prerequisites

• Keen interest in Project Management, Process improvement and Operational Efficiency.
• Strong analytical and problem-solving skills.
• Proficiency in data analysis tools and project management software.
• Excellent communication and interpersonal skills.
• Ability to work independently

Marina Bay Sands is committed to building a diverse, equitable and inclusive workforce, providing equal opportunities as we grow our talent base to match our growth ambitions in Singapore. Our employees are committed to adhere to and abide by all rules, regulations, policies and procedures, including the rules of conduct and business ethics of the Company.

WE TAKE YOU ABOVE BEYOND

Take your passion to the next level and work alongside other masters of their craft to build a fulfilling and rewarding career at Marina Bay Sands.

Job Responsibilities

• Process Analysis and Improvement:
• Assist in the analysis of current operational processes to identify inefficiencies and areas for improvement.
• Utilize principles of Lean, Kaizen 5S, and other process improvement methodologies to drive efficiency.
• Resource Optimization:
• Assist in monitoring resource allocation using data to ensure optimal utilization.
• Assist in implementing best practices for resource management to reduce waste and improve productivity.
• Inventory Management:
• Assist in monitoring inventory levels to ensure optimal stock levels and minimize excess inventory.
• Assist in implementing inventory control procedures to improve accuracy and reduce discrepancies.
• Assist in regular inventory audits.
• Data Analysis and Reporting:
• Assist in collecting and organizing data to measure the effectiveness of process improvements.
• Assist in preparing reports and presentations on operational performance and improvement outcomes.
• Compliance and Quality Assurance:
• Ensure that all operational processes comply with legal regulations and industry standards.
• Implement quality control measures to maintain high standards of operational performance

Job Requirements

Education & Certification

• Applicant must be a full-time matriculated student.
• Internship must contribute to school graduation requirements.

Experience

• No experience required as training will be provided

Other Prerequisites

• Keen interest in Project Management, Process improvement and Operational Efficiency.
• Strong analytical and problem-solving skills.
• Proficiency in data analysis tools and project management software.
• Excellent communication and interpersonal skills.
• Ability to work independently

Marina Bay Sands is committed to building a diverse, equitable and inclusive workforce, providing equal opportunities as we grow our talent base to match our growth ambitions in Singapore. Our employees are committed to adhere to and abide by all rules, regulations, policies and procedures, including the rules of conduct and business ethics of the Company.

At DuPont, our purpose is to empower the world with essential innovations to thrive. We work on things that matter. Whether it's providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric vehicles, or protecting workers around the world. Discover the many reasons the world's most talented people are choosing to work at DuPont. Why Join Us | DuPont Careers

About the Role

You will be the Process Engineer reporting to our Plant Manager. You play a critical role in production organization as a technical resource for operations personnel. You apply technical skills to optimize plant operations, resolve plant problems, and enable safe and efficient production of low cost, quality products. You work with internal and external subject matter experts to implement best practices to drive positive change onsite.

You are inquisitive, analytical, data-driven, process-oriented. You have experience or knowledge in plant automation and robotic. Work location is Tuas West manufacturing site.

Responsibilities:

• Act as a resource to guide teams on applicable process technology, equipment and controls technology. Works with plant personnel to meet/exceed business and plant goals (safety, quality, reliability, cost, etc.)
• Lead and participate in safety and quality investigations. Drive root cause analysis to identify contributing factors and implement sustainable improvements.
• Analyze trends in manufacturing process, to define underlying causes of waste
• Lead teams of associates to identify and implement continuous improvement for quality, yield and productivity.
• Spearhead process automation control upgrades or other modifications for product/process improvement
• Network with other engineers and experts globally to leverage knowledge and best practices. Be the advocate of such practices for Operations.

Requirements:

• Bachelor's degree or Diploma in Electrical and Instrumentation, Mechanical, Electrical and Electronics, or Automation control background.
• Minimum 5 years of working experience in a manufacturing or industrial facility.
• Lean Six Sigma Green Belt certified.
• Knowledge and experience in powdered metal processing and or plastic injection molding is an added advantageous.

Join our Talent Community to stay connected with us

DuPont is an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class. If you need a reasonable accommodation to search or apply for a position, please visit our Accessibility Page for Contact Information.

DuPont offers a comprehensive pay and benefits package. To learn more visit the Compensation and Benefits page.

We are committed to delivering patient-focused solutions that revolutionize the pharmaceutical industry.

• Collaborate with Maintenance, Engineering, and Automation teams to identify and implement process enhancements.
• Evaluate and deploy digital tools to improve equipment reliability and efficiency.
• Develop data management systems and visualizations for equipment and system performance metrics.
• Support the introduction of new technologies, improvement projects, and EIO package development.
• Act as liaison across teams for SOPs, Work Orders, Job Plans, and documentation updates.
• Review and ensure accuracy of maintenance documentation, signatures, and revisions.
• Participate in GEMBA/system walk-downs and follow up on action items.
• Perform other assignments as directed by the Maintenance Manager.

• Degree in Engineering or related field is required.
• Fresh graduates are welcome to apply.

Competitive Compensation Package
Comprehensive Health & Wellness Coverage Professional Development Opportunities Inclusive Culture Shape the Future

Our company is seeking a highly skilled Process Improvement Specialist to join our team. In this role, you will be responsible for analyzing and evaluating current processes, taking measurements, and interpreting data. This includes SCADA system operations, risk assessments to ensure safe operations, and researching, designing, and developing processes to improve productivity and workflow.

• Analyze and evaluate current processes
• Conduct risk assessments to ensure safe operations
• Research and develop new processes to improve productivity and workflow
• Oversee day-to-day operations and maintenance of facility processes
• Manage the implementation of new processes and procedures
• Troubleshoot and resolve issues related to processes, procedures, and operations
• Develop best practices, routines, and innovative solutions to improve output and quality
• Manage process costs and timelines
• Prepare process documentation and operating instructions

Additional responsibilities include participating in Process Safety Management (PSM) and Hazard and Operability (Hazop) studies, as well as planning and executing plant shutdowns as a turn-key manager.

• Bachelor's degree in Chemical Engineering
• At least 2 years of experience in the process industry
• Good knowledge of process standards, process improvement, and safety management
• Team-oriented and adaptable