Total 8 quality assurance executive job vacancies in d23 hillview dairy farm bukit panjang choa chu kang

Job Description & Responsibilities:

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Work with technical team to create quality document related to product design, development and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Develop and evaluate medical device regulatory intelligence and maximize opportunities to expedite the registration process within S.E.A region, China and USA. Activities include obtaining and maintaining domestic and regional market access for our innovative products.
• Provide appropriate inputs to assist in defining regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical devices.
• Compile technical, clinical and production protocols and documentations necessary for new products dossier submission to S.E.A. region, China and USA. regulatory submissions. Liaise with technical team (locally and internationally) on technical information required to prepare submission dossiers. Manage preparation (developing submission content, management of document legalization, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan.
• Overall responsible for ensuring that medical device files are set up in compliance to regulatory requirement.
• Monitor and communicate new and changing medical device law, guidance regulations in a timely manner. Reviews process change recommendation and assists in implementing new procedures and documentation.
• Ensure that regulatory records are controlled and maintained.
• Train internal and external stakeholders on regulatory data management processes and platforms, regulatory matters and product registration.

Job Requirements:

• Master or Bachelor of Science/Engineering with strong background in biomedical, computer or engineering sciences.
• Possess 3 years or more of working experience in quality assurance and regulatory affairs in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge of Health Sciences Authority requirement for IVD product submission.
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Experience with product registration submission and evaluation.
• Experience with maintaining internal regulatory database.
• Experience with Dossier Creation.
• Ability to develop and implement plans for regulatory submission.
• Awareness of applicable workplace environment, health and safety regulations.
• Ability to network and build strategic partnership with good problem solving skills and communication skills.
• Possess leadership and agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Master's degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Bachelor’s degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Description:

• Support procurement process at DxD Hub, ensuring technical and policy compliance as well as value-for-money.
• Structuring requirements for procurement process: Translate purchase requests from technical team to online procurement systems.
• Perform and/or support activities throughout procurement process. Example activities include creating internal approval memos and justification, preparing external documents (e.g. Invitation to Quote, Tenders).
• Support proposal evaluation: work with users to perform structured assessment of vendor proposals and recommend proposal to award.
• Partner with executives in other functions including Procurement and Finance to ensure efficient operations.
• Collate and track data to support analysis, including maintaining databases and hard copy records.
• Ensure that database is updated in a timely and accurate manner.
• Provide general administrative and clerical support to DxD Hub Team ensuring safe and comfortable DxD Hub operations.
• General administrative and clerical support to DxD Hub Team.
• Manage and monitor inventory of office and pantry supplies and re-order as needed.
• Track non-scientific equipment and assets (e.g. video conferencing system, furniture) and work with vendors for maintenance.
• Monitor facilities vendors (e.g. cleaning, telecom) to ensure a comfortable office environment for staff including light clean-up as needed.
• Work closely with SpIA and HR for the issuance of staff card for new hires and ensure that the staff has access to all DxD office sites.

Job Requirements:

• Diploma holder with a certificate in professional secretarial skills/ finance.
• Minimum 2 years of relevant experience in similar capacity.
• Experience in purchasing of biomedical consumables and equipment would be an advantage.
• Proficient in MS Office Applications, including Word, Excel, PowerPoint, and Outlook.
• A team player with excellent interpersonal, communication and organisational skills.
• Able to communicate effectively, multi-task, and work in a dynamic environment.
• Well organised and good written communication skills.
• Awareness of workplace health and safety would be an advantage.
• Meticulous and able to work independently in a fast-paced environment.
• Individual who is self-motivated, and results driven.
• Proactive and takes ownership of projects.
• Adaptable and able to work under pressure.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Description:

• Support procurement process at DxD Hub, ensuring technical and policy compliance as well as value-for-money.
• Structuring requirements for procurement process: Translate purchase requests from technical team to online procurement systems.
• Perform and/or support activities throughout procurement process. Example activities include creating internal approval memos and justification, preparing external documents (e.g. Invitation to Quote, Tenders).
• Support proposal evaluation: work with users to perform structured assessment of vendor proposals and recommend proposal to award.
• Partner with executives in other functions including Procurement and Finance to ensure efficient operations.
• Collate and track data to support analysis, including maintaining databases and hard copy records.
• Ensure that database is updated in a timely and accurate manner.
• Provide general administrative and clerical support to DxD Hub Team ensuring safe and comfortable DxD Hub operations.
• General administrative and clerical support to DxD Hub Team.
• Manage and monitor inventory of office and pantry supplies and re-order as needed.
• Track non-scientific equipment and assets (e.g. video conferencing system, furniture) and work with vendors for maintenance.
• Monitor facilities vendors (e.g. cleaning, telecom) to ensure a comfortable office environment for staff including light clean-up as needed.
• Work closely with SpIA and HR for the issuance of staff card for new hires and ensure that the staff has access to all DxD office sites.

Job Requirements:

• Diploma holder with a certificate in professional secretarial skills/ finance.
• Minimum 5 years of relevant experience in similar capacity.
• Experience in purchasing of biomedical consumables and equipment would be an advantage.
• Proficient in MS Office Applications, including Word, Excel, PowerPoint, and Outlook.
• A team player with excellent interpersonal, communication and organisational skills.
• Able to communicate effectively, multi-task, and work in a dynamic environment.
• Well organised and good written communication skills.
• Awareness of workplace health and safety would be an advantage.
• Meticulous and able to work independently in a fast-paced environment.
• Individual who is self-motivated, and results driven.
• Proactive and takes ownership of projects.
• Adaptable and able to work under pressure.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

About Us:

EDDC is a dynamic and rapidly growing organisation committed to excellence and innovation. We are seeking an experienced Executive Manager to provide high-level support to our Senior Management/Leadership Team (C-Suite executives) at EDDC, ensuring their schedules are efficiently managed, administrative briefs are meticulously prepared, and contracts (NDA and CDA) for scientific procurement and project needs are expertly managed.

Job Description:

The successful candidate will be supporting the C-Suite executives at EDDC, you will work closely with executives, deliver efficient secretarial and administrative support in a well-organised manner to ensure daily administrative tasks run smoothly. You will also be responsible for contract management, particularly Non-Disclosure Agreements (NDAs) and Confidentiality Disclosure Agreements (CDAs) related to scientific procurement and projects.

Key Responsibilities:

1. Schedule Management : Effectively manage and optimise the calendars of C-Suite executives, coordinating internal and external meetings, appointments, and travel arrangements.

2. Administrative Briefs : Prepare comprehensive and confidential administrative briefs, reports, and documentation for the C-Suite, ensuring accuracy and timely delivery.

3. Contract Management : Oversee the creation, execution, and management of NDAs and CDAs for scientific procurement and project requirements, ensuring compliance with legal and organizational standards.

4. Communication Liaison : Act as a central point of contact between C-Suite executives and various internal and external stakeholders, ensuring seamless communication and responsiveness.

5. Develop meeting agendas : Organise, facilitate, and follow up on executive meetings, including preparing agendas, minutes, and action items.

6. Strategic Support : Assist in strategic projects, including research, data analysis, and providing insights to support decision-making.

7. Confidentiality : Maintain the highest level of confidentiality and discretion in handling sensitive information.

8. Team Collaboration : Collaborate with administrative teams to streamline processes and support cross-functional initiatives.

Requirements :

• Diploma/Bachelor Degree in Business Administration, Management, or a related field.
• Proven experience in executive support, scheduling for senior executives, and contract management
• Exceptional organisational and time management skills
• Excellent written and verbal communication skills
• Proficiency in office software and scheduling tools (e.g. Microsoft Office)
• Strong problem-solving and decision making abilities
• Ability to work under pressure and adapt to changing priorities
• Prior experience in a similar role supporting C-Suite executives
• Project Management experience
• Familiarity with contract management software and legal documentation

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

We are seeking a highly motivated Executive to contribute to our Business Development Group. This role offers an exciting opportunity to drive innovation and efficiency in our BD processes, utilizing cutting-edge technology and AI-assisted automation.

Key Responsibilities:

• Spearhead the enhancement and implementation of our BD operations processes through the integration of new technologies and AI-assisted automation, driving productivity and effectiveness.
• Play a pivotal role in updating and maintaining BD content and databases, ensuring accuracy and accessibility of critical information on platforms such as SharePoint, CRM, and others.
• Provide comprehensive support for the Target Translation Consortium (TTC), a national initiative coordinated by EDDC, overseeing administrative, logistical, and secretarial functions. This includes managing databases, coordinating meetings, workshops, and roadshows, and maintaining relevant documentation to facilitate collaboration within the consortium.
• Uphold confidentiality and compliance standards in all BD processes, ensuring the security of sensitive information and adherence to regulatory requirements. Participate in audit exercises as required
• Manage the day-to-day operations of the BD team, including scheduling and organizing the roster within the BD group to optimize workflow efficiency.
• Perform and negotiate simple contracts such as NDA (Non-Disclosure Agreement)

Requirements:

• Degree or Diploma (with at least 5 years of relevant experience) in Information Technology-related discipline
• Minimum of 3 years of relevant work experience
• Excellent organizational and communication skills
• Strong attention to detail and a meticulous approach to tasks
• Good spoken and written communication skills
• Sound understanding of compliance, auditing, and quality control principles
• Resourceful with the ability to work independently and with minimal supervision
• A team player with excellent collaborative skills
• Takes ownership of tasks, is self-motivated and pro-actively solves problems
• A keen interest in innovation and willingness to explore new approaches
• Proficient in Outlook calendar and Microsoft Office Applications

Joining our team offers an exciting opportunity to apply your expertise and contribute to our mission of driving innovation in drug discovery and development. If you possess the required qualifications and are motivated to excel in a dynamic environment, we invite you to apply and be part of our team.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

About Us:

EDDC is a dynamic and rapidly growing organisation committed to excellence and innovation. We are seeking an experienced Executive Manager to provide high-level support to our Senior Management/Leadership Team (C-Suite executives) at EDDC, ensuring their schedules are efficiently managed, administrative briefs are meticulously prepared, and contracts (NDA and CDA) for scientific procurement and project needs are expertly managed.

Job Description:

The successful candidate will be supporting the C-Suite executives at EDDC, you will work closely with executives, deliver efficient secretarial and administrative support in a well-organised manner to ensure daily administrative tasks run smoothly. You will also be responsible for contract management, particularly Non-Disclosure Agreements (NDAs) and Confidentiality Disclosure Agreements (CDAs) related to scientific procurement and projects.

Key Responsibilities:

1. Schedule Management : Effectively manage and optimise the calendars of C-Suite executives, coordinating internal and external meetings, appointments, and travel arrangements.

2. Administrative Briefs : Prepare comprehensive and confidential administrative briefs, reports, and documentation for the C-Suite, ensuring accuracy and timely delivery.

3. Contract Management : Oversee the creation, execution, and management of NDAs and CDAs for scientific procurement and project requirements, ensuring compliance with legal and organizational standards.

4. Communication Liaison : Act as a central point of contact between C-Suite executives and various internal and external stakeholders, ensuring seamless communication and responsiveness.

5. Develop meeting agendas : Organise, facilitate, and follow up on executive meetings, including preparing agendas, minutes, and action items.

6. Strategic Support : Assist in strategic projects, including research, data analysis, and providing insights to support decision-making.

7. Confidentiality : Maintain the highest level of confidentiality and discretion in handling sensitive information.

8. Team Collaboration : Collaborate with administrative teams to streamline processes and support cross-functional initiatives.

Requirements :

• Diploma/Bachelor Degree in Business Administration, Management, or a related field.
• Proven experience in executive support, scheduling for senior executives, and contract management
• Exceptional organisational and time management skills
• Excellent written and verbal communication skills
• Proficiency in office software and scheduling tools (e.g. Microsoft Office)
• Strong problem-solving and decision making abilities
• Ability to work under pressure and adapt to changing priorities
• Prior experience in a similar role supporting C-Suite executives
• Project Management experience
• Familiarity with contract management software and legal documentation

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.