Expected salary: $80,000 - $90,000 per year
4DMedical is an ASX listed global medical technology company aiming to improve the outcomes for patients with lung disease by revolutionising respiratory imaging and ventilation analysis. We utilise cutting-edge algorithms from mechanical engineering, image processing and mathematics to build proprietary Software as a Service (SaaS) based products that deliver new insights into lung function and patient health.
Responsibilities and Duties (include but are not limited to)
Position Specific Duties
· Administering 4DMedical’s electronic QMS
· Training 4DMedical team members on the function and use of the Quality Management System and associated tools.
· Maintain training for Quality System Documentation within the e-QMS.
· Assist in training team members on the function and use of the Quality Management System, relevant internal and external global quality standards, policies, procedures and requirements.
· Work with 4Dmedical colleagues and external consultants to develop and execute 4DMedical’s quality and regulatory strategies, consistent with business objectives.
· Preparation, collation and maintenance of medical device quality documentation ensuring compliance with health authority/notified body requirements and relevant Australian and International standards.
· Preparation, collation, and maintenance, of medical device product documentation in accordance with business objectives and ensuring compliance with health authority requirements and relevant Australian and International standards.
· Assist in the management of post market surveillance, product complaints and post market feedback, including assessment, escalation and reporting thereof.
· Assist with progression of non-conformances and CAPAs in the eQMS. .
· Identifying, documenting, co-ordinating and implementing corrective and preventive actions.
· Maintenance of databases related to quality activities (eg. data entry, and memos to file).
· Compliance with all 4DMedical systems and processes.
· Authoring, reviewing, approving, and processing QMS documents.
· Raising, co-ordinating and processing change controls.
· Organising change control meetings, including setting and distributing agenda and recording minutes if applicable.
· Conducting internal audits.
· Participating in audits of 4DMedical by health authorities, notified bodies and other bodies.
· Participating in the Vendor Assurance program, including assessing, auditing, and approving new suppliers.
· Performing additional tasks requested by Director of Quality and Management that are related to the quality functions of the organisation.
Experience and Qualifications
>2 years working in the medical devices, pharmaceutical or biotechnology industries in a compliance focussed or quality role.
· Tertiary qualified, preferably in a science-related discipline (e.g. sciences, engineering, etc).
People of all ages, genders, and backgrounds are encouraged to apply. We are an Equal Opportunity employer, providing a dynamic, supportive work environment.
As this role involves significant collaboration this position is not offered as a remote working role.
This role is located in Carlton office and candidates will be expected to spend significant time in the office.
We are looking to fill this position immediately and require candidates to be available to start ASAP
4DMedical provides an inclusive work environment and embraces the diverse talent of its people.
4DMedical is an ASX listed global medical technology company aiming to improve the outcomes for patients with lung disease by revolutionising respiratory imaging and ventilation analysis. We utilise cutting-edge algorithms from mechanical engineering, image processing and mathematics to build proprietary Software as a Service (SaaS) based products that deliver new insights into lung function and patient health.
Responsibilities and Duties (include but are not limited to)
Position Specific Duties
· Administering 4DMedical’s electronic QMS
· Training 4DMedical team members on the function and use of the Quality Management System and associated tools.
· Maintain training for Quality System Documentation within the e-QMS.
· Assist in training team members on the function and use of the Quality Management System, relevant internal and external global quality standards, policies, procedures and requirements.
· Work with 4Dmedical colleagues and external consultants to develop and execute 4DMedical’s quality and regulatory strategies, consistent with business objectives.
· Preparation, collation and maintenance of medical device quality documentation ensuring compliance with health authority/notified body requirements and relevant Australian and International standards.
· Preparation, collation, and maintenance, of medical device product documentation in accordance with business objectives and ensuring compliance with health authority requirements and relevant Australian and International standards.
· Assist in the management of post market surveillance, product complaints and post market feedback, including assessment, escalation and reporting thereof.
· Assist with progression of non-conformances and CAPAs in the eQMS. .
· Identifying, documenting, co-ordinating and implementing corrective and preventive actions.
· Maintenance of databases related to quality activities (eg. data entry, and memos to file).
· Compliance with all 4DMedical systems and processes.
· Authoring, reviewing, approving, and processing QMS documents.
· Raising, co-ordinating and processing change controls.
· Organising change control meetings, including setting and distributing agenda and recording minutes if applicable.
· Conducting internal audits.
· Participating in audits of 4DMedical by health authorities, notified bodies and other bodies.
· Participating in the Vendor Assurance program, including assessing, auditing, and approving new suppliers.
· Performing additional tasks requested by Director of Quality and Management that are related to the quality functions of the organisation.
Experience and Qualifications
>2 years working in the medical devices, pharmaceutical or biotechnology industries in a compliance focussed or quality role.
· Tertiary qualified, preferably in a science-related discipline (e.g. sciences, engineering, etc).
People of all ages, genders, and backgrounds are encouraged to apply. We are an Equal Opportunity employer, providing a dynamic, supportive work environment.
As this role involves significant collaboration this position is not offered as a remote working role.
This role is located in Carlton office and candidates will be expected to spend significant time in the office.
We are looking to fill this position immediately and require candidates to be available to start ASAP
4DMedical provides an inclusive work environment and embraces the diverse talent of its people.
