Total 11 research nurse job vacancies in Quality Assurance / Control category in D05 Clementi New Town, Hong Leong Garden, Pasir Panjang

DxD Hub QA/Lab Operations Team is seeking candidate to join the team to build capabilities needed for lab operation in medical device organization.

You will join the QA and Lab Operations team to implement QMS requirement and laboratory safety protocols in the management of equipment, facilities and inventory within the product development laboratory.

You will be trained in the following areas:

Competency in ISO 13485:2016

• Understanding concept of ISO 13485:2016 standard and the impact of the requirements on lab operations.
• Management of Change.
• Management of deviation and nonconformity.
• CAPA and root cause analysis.

Workplace Safety, Health and Environment

• Application of safe work procedures in work activities.
• Workplace safety incident investigation.
• Proper classification, handling, storage and disposal of lab chemicals including toxic, corrosive, flammable chemicals.
• Proper handling, storage and disposal of biological materials.
• Emergency response.

Facility Management

• Regulatory requirement for lab operations.
• Regulatory guideline for waste management.

Equipment Maintenance

• Understand the purpose of equipment calibration.
• Understand concept of accuracy and tolerance in calibration results.

Equipment Qualification

• Understand the principles of equipment qualification.
• Writing qualification protocol and report.
• Execute basic installation and operations qualification protocols.

You will support the QA and lab operations team in the following:

• Receiving and inspection of material and equipment.
• Equipment qualification: develop qualification protocol/report, plan for qualification activities.
• Support in maintenance of lab facility compliant to ISO 13485 and regulatory requirement.
• Review/drafting of SOP.
• Participate in audit.
• Record NCR and conduct CAPA process.
• Participate in lab improvement project.
• Cross division activities on adhoc basis.

Job Requirements

• Bachelor of Science or Engineering with knowledge in engineering science.
• Working knowledge in Microsoft office.
• Good communication and presentation skill.
• Individual who is highly motivated, results driven and well organized.
• Possess intellectual agility and a strong team player.
• Applicants with no experience may apply.

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.
• 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 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 & 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:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

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:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

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:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Minimum Diploma, preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

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:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

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:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

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.

A world empowered by autonomy. We build robotic vehicles to improve logistics safety, forge a greener Earth, and enhance human lives.

We are a closely-knit team aspiring to change the world through disruptive technology. We are innovators. We are tinkerers. We are problem-solvers. And we have a fair amount of magic dust up our sleeves. We have a plan for fleet-level deployment of autonomous vehicles, and we are looking for the best-of-the-best to join us in making this a reality.

About Venti Technologies

Based in the U.S. and Asia, Venti Technologies is the leader in safe-speed autonomous logistics systems, developing the future of goods transportation. Using rigorous mathematics, deep learning, and theoretically-grounded algorithms, Venti has a proprietary collection of autonomy technologies including a suite of powerful logistics algorithms. Venti’s proven value proposition of saving costs, increasing vehicle utilization, and improving safety is recognized by customers and driving growth. Launched in 2018, Venti brings together an unsurpassed team internationally. The company has autonomous systems deployed in Asia for industrial and logistics sites and a growing pipeline. Venti has offices in Cambridge (Massachusetts, USA), Suzhou (China), and Singapore – our Asian headquarters.

Role responsibilities

• To keep abreast of the current state-of-the-art motion control algorithms
• To develop a variety of trajectory tracking algorithms (path and speed profile)
• To account for vehicle dynamics subject to variable loading of towed trailers
• Software design and development

Required experience

• Ideally 1+ years of experience in control research domain.
• Bachelors in computer science, Robotics, or related fields
• Strong familiarity with control systems, robotics, autonomous vehicles
• Strong familiarity with trajectory optimization
• Experience with research in robotics or related fields involving realistic agent motion
• Experience with C++ in a Linux environment
• Flexible problem-solver

Bonus experience

• Experience with ROS or other similar middleware
• Experience with data structures, object-oriented programming
• Experience with real world robotics deployment
• Experience in data-analysis
• Experience in simulation

Salary is commensurate with experience. We also offer world-class benefits, fantastic culture, flexible working arrangements, and a great international working environment. Come and join us!

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

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.