Australian Medical Technology company developing implantable brain‐monitoring technology, aiming to transform how epilepsy condition is diagnosed and managed, this opportunity can work from anywhere in Australia or have a base in Sydney & Melbourne.
About the Role
Provide independent quality representation across all programs, projects, and clinical activities.
Responsibilities
* Develop and execute the long‐term QMS strategy to support US market entry and commercial objectives.
* Manage the Quality Management System (QMS) in accordance with ISO 13485 and FDA QMSR (21 CFR Part 820).
* Ensure alignment with business and commercial requirements and industry best practices.
* Obtain and maintain ISO 13485 certification.
* Lead the continuous improvement of the Quality Management System (QMS) to ensure compliance to FDA QMSR (21 CFR Part 820) and ISO 13485 requirements.
* Generate and support generation of quality processes, policies, work instructions, and other quality outputs required to maintain compliance and support clinical and development activities.
* Provide oversight of company quality processes and objectives, and drive continuous improvement activities.
* Ensure promotion and awareness of QMS requirements throughout the organisation.
* Maintain and ensure alignment of quality processes across design and manufacturing activities, and other critical suppliers.
* Lead post‐market surveillance, management reviews, complaint handling, CAPA, and nonconformance processes.
* Support product development teams to ensure integration of quality and regulatory requirements at all project stages.
* Support the CTO with change requests, ensuring communications and processes are followed across QMS systems.
* Manage internal and supplier audit programs, ensuring supplier qualification and ongoing performance monitoring.
* Interact with quality team members to manage design and manufacturing interfaces and ensure alignment.
* Report directly to the CEO and management team on QMS performance, quality issues, and escalations.
* Engage with critical suppliers to ensure compliance, audit readiness, and product quality.
Qualifications
Minimum 7 years in medical device development and leadership, including experience with implantable devices and Class II/III regulatory pathways.
Required Skills
* Experience in setting up and managing Medical Device Quality Systems.
* Experience taking active implantable medical devices to clinical trial and market.
* Experience conducting and supporting technical and quality audits.
* Experience developing products in compliance with IEC 60601, ISO 14971, and IEC 62304.
* Demonstrated expertise in regulatory submissions (FDA 510(k), PMA, TGA, CE Mark).
* Experience leading and scaling teams, supplier quality, post‐market compliance, and audits.
* Excellent written and verbal communication skills with ability to engage regulatory agencies and executive stakeholders.
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