QA Associate

Emvision Medical Devices; Sydney; On-site; AUD 65,000 - 85,000; Full time

Job summary

EMVision Medical Devices is seeking an experienced QA Associate to support the implementation, maintenance and continual improvement of our QMS. You will provide operational and administrative quality support across documents, records, training administration and supplier management.

Reporting to the QA Manager, you will help ensure medical devices and activities comply with ISO 13485, MDR, MDSAP, FDA and other market regulations.

Qualifications

• Completed diploma, degree or other relevant tertiary qualification.
• Training in quality management systems or document control.
• Strong written and verbal communication skills.
• Strong knowledge of MS Office packages (e.g. Excel, Outlook, Word, PowerPoint).
• Ability to follow approved procedures and instructions.
• Reliable, responsible and willing to learn.
• Able to work collaboratively and communicate respectfully.
• Comfortable seeking guidance and escalating issues when required.

Responsibilities

• Provide administrative support for the maintenance of the QMS, including document and record control procedures.
• Perform formatting, uploading, archiving documents and records.
• Assist with drafting QMS documents using approved templates.
• Monitor actions and follow up on overdue items.
• Assist with quality events, including change controls, nonconformances, CAPAs, deviations and complaints.
• Maintain supplier qualification documents and approved supplier records.
• Escalate incomplete or incorrect documentation to the QA Manager.
• Execute QMS-related activities per EMVision procedures and work instructions.
• Assist with development and improvement of QMS processes.

Skills

Quality mindset

Communication skills

Attention to detail

Learning agility

Education

Diploma or degree

Tools

MS Office

Job description

Emvision Medical Devices – Macquarie Park NSW

• Winner of multiple design awards in 2025/2026 and the AFR 2023 Most Innovative Companies Award in Healthcare.
• Medical device industry, based in Macquarie Park.
• Opportunity to join a progressive and well-funded start-up Company.

Join EMVision and help shape the future of neurodiagnostics. We are developing and commercialising innovative, world-class portable brain scanner products designed to transform the timely diagnosis and treatment of neurological emergencies, including stroke. Our technology has the potential to positively impact millions of patients globally by enabling diagnosis closer to the patient, wherever they are located.

EMVision Medical Devices Ltd (ASX:EMV) is a publicly listed medical technology company with ambitions to reduce the global burden of stroke and traumatic brain injury. Our first commercial product, the emu™ in-hospital brain scanner, is currently undergoing an international pivotal trial at leading centres including Mayo Clinic, UCLA, UTHealth and Mt Sinai to support regulatory clearance. Our second product, the First Responder pre-hospital scanner, is following closely behind.

As we transition from a strong R&D focus toward commercialisation and market entry, we are seeking an experienced QA Associate to support the implementation, maintenance and continual improvement of our Quality Management System.

About the role

Key to this role is the ability to provide operational and administrative quality support across document and record control, training administration, supplier management, quality events, audits, QMS software validation and other similar QMS processes.

You will have the opportunity to support the organisation in ensuring that medical devices and associated activities are conducted in accordance with approved procedures, product requirements and applicable quality and regulatory requirements, including ISO 13485, the Australian Therapeutic Goods legislation, European Medical Device regulations (MDR), the Medical Device Single Audit Program (MDSAP), US FDA requirements and other applicable market regulations.

This is an opportunity to contribute to a progressive, well-funded start-up environment as we pursue a United States first approach, global expansion ambitions, and the establishment of a pilot production line in Sydney.

Key Responsibilities

Reporting to the QA Manager, the key responsibilities include:

• Provide administrative support for the maintenance of the QMS, specifically performing administrative completeness checks of QMS documents and records.
• Complete QMS administrative activities, including formatting, uploading, archiving documents and records.
• Assist with drafting QMS documents using approved templates, where applicable.
• Monitor assigned actions and follow up on overdue actions.
• Assist with administering quality events, including change controls, nonconformances, CAPAs, deviations and complaints.
• Maintain supplier qualification documents, certificates and approved supplier records.
• Escalate incomplete or incorrect documentation to the Manager.
• Execute QMS-related activities in accordance with EMVision's defined procedures and work instructions.
• Assist with the development and improvement of QMS-related processes.

General Accountabilities

• Follow approved procedures, work instructions and directions provided by authorised personnel.
• Complete assigned training within required timeframes.
• Apply good documentation and data-integrity practices when creating or updating records.
• Maintain the confidentiality and security of quality, product, employee and business information.
• Promptly report errors, missing information or potential quality issues to the Manager.

About you

To be successful in this role, you will bring:

• Completed diploma, degree or other relevant tertiary qualification.
• Training in quality management systems or document control.
• Strong written and verbal communication skills.
• Strong knowledge of MS Office packages (e.g. Excel, Outlook, Word, PowerPoint).
• Ability to follow approved procedures and instructions.
• Reliable, responsible and willing to learn.
• Able to work collaboratively and communicate respectfully.
• Comfortable seeking guidance and escalating issues when required.

Desirable but not essential:

• Previous administrative, document-control or records-management experience.
• Experience in a medical-device or other regulated industry.