Quality Manager

• Winner of 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.
• Work on world first products set to transform stroke care.

Join EMVision and be a part of a company developing and commercialising game changing portable brain scanner products to transform stroke care and in doing so positively impact the lives of millions globally.

Having just been named the top innovator in healthcare for the AFR 2023 Most Innovative Companies, EMVision is developing point-of-care brain scanners, for rapid stroke diagnosis and monitoring, wherever the patient is located. 

We are looking for a Quality Manager to develop, implement and maintain the QMS in accordance with the appropriate standards and requirements, including but not limited to ISO 13485, European Medical Device Regulations and FDA 21 CFR 820.

Key to this role is an ability to work cross-functionally, being hands-on to complete the necessary deliverables for implementing the QMS, whilst also operating at a management level. 

EMVision is a young company commercialising an exciting product, and this role is important for establishing a QMS for company growth.

Working as part of a team, and reporting through to the Head of Regulatory Affairs, the key responsibilities of this role include:

• Acting as the Management Representative for the Quality Management System, including acting as lead auditee in QMS audits.
• Executing EMV’s Quality Assurance and Quality Control strategies.
• Ensure employees follow EMV’s Quality Management System and provide training as required.
• Responsible for QMS processes including Document Control, Change Control, Training, Supplier Control, Control of Non-Conforming Product, CAPA, and Audits, and others as determined through the development, implementation, and maintenance of the Quality Management System.
• Review deliverables across the organisation to ensure compliance with established QMS procedures, QC requirements and a high standard of quality.
• To be accountable, as follows:
• Ensure EMV complies with applicable requirements of ISO 13485, EU MDR and FDA 21 CFR 820, as well as any other applicable QMS requirements.
• Ensure product is designed and developed in line with QMS requirements. 
• Ensure the QMS is executed in compliance with applicable regulatory requirements.

If you have the following skills, qualities, and experience, we would like to hear from you:

• Relevant tertiary qualifications in Scientific or Engineering fields.
• Minimum of 5 years of experience in medical device Quality Assurance.
• Working knowledge of the requirements of ISO 13485 Quality Management Systems, European MDR and FDA Quality System Regulations (QSR).
• Auditor in Quality Management Systems.
• High level documentation and systems management experience, with advanced skills in software.
• High level communication and negotiation skills, with good presentation skills.
• Ability to meet deadlines consistently, with a proactive, pragmatic, and commercial focus.
• Excellent ability to build robust relationships, both internally and externally, including:
• Strong gravitas and influencing skills to be the voice of the Company for quality matters. 
• The ability to influence internal and external stakeholders at all levels - including regulatory agencies and quality consultants. 
• Excellent interpersonal and communication skills.
• A self-driven team player who thrives in collaborative environments.
• An entrepreneurial mindset and strong business acumen, including the ability to meet the Company’s financial objectives whilst ensuring quality compliance, is essential for success in this role.

For further information about this opportunity, or to submit your application, please contact:

Kirste Courtney

Human Resources Manager

*********@emvision.com.au