Employment Type: Hybrid, Full-time

Position Summary The QA Manager is responsible for leading the day-to-day Quality Assurance function in Australia and managing the local QA team to ensure the effective implementation, maintenance and continuous improvement of Genea Biomedx’s Quality Management System (QMS).

Reporting to the Global QA/RA Director, the QA Manager will translate global quality strategy, policies and regulatory requirements into effective local execution. The role will provide leadership and oversight across quality systems, compliance, audits, CAPA, non-conformances, change control, supplier quality, training, document control, manufacturing and product quality activities.

As the local QA people manager, the position is responsible for establishing clear priorities, allocating resources, developing team capability and ensuring timely completion of quality activities. The QA Manager will work closely with Regulatory Affairs, Manufacturing, QC, R&D;, Supply Chain, Engineering and other global functions to maintain a compliant and effective quality system supporting Genea Biomedx’s medical device operations.

Key Responsibilities

1. QA Team Leadership & Management

- Lead, manage and develop the Australia-based QA team, including setting objectives, priorities and performance expectations.

- Allocate QA resources and responsibilities according to business, operational and compliance priorities.

- Provide coaching, technical guidance and ongoing development to QA team members.

- Conduct regular team meetings, one-on-one discussions and performance reviews.

- Monitor team workload, deliverables and timelines and escalate resource or compliance risks to the Global QA/RA Director where appropriate.

- Build a strong culture of quality, accountability, collaboration and continuous improvement within the QA team.

- Ensure effective communication and coordination between the Australian QA team and other global QA/RA colleagues.

2. Quality Management System

- Manage the day-to-day implementation and maintenance of the Genea Biomedx QMS in accordance with applicable regulatory and quality requirements.

- Ensure compliance with ISO 13485 and other applicable medical device regulations and standards.

- Oversee key QMS processes including:

- CAPA

- Non-conformances

- Deviations

- Change control

- Document and record control

- Quality training

- Complaint-related quality activities

- Supplier quality

- Internal audits

- Management review inputs and follow-up actions

- Monitor QMS performance and identify systemic issues, recurring trends and opportunities for improvement.

- Ensure quality records and documentation are accurate, complete, traceable and maintained in accordance with applicable requirements.

3. Manufacturing & Operational Quality

- Provide QA oversight and support to manufacturing and operational activities conducted at the Australian site.

- Work closely with Manufacturing and QC teams to ensure products are manufactured, inspected, tested and released in accordance with approved procedures and specifications.

- Support investigation and disposition of non-conforming materials, components and products and complaints handling

- Ensure appropriate quality oversight of manufacturing process changes, equipment changes, validation activities and production-related deviations.