Total 9 quality assurance control job vacancies in haymarket new south wales

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:

• 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.

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.