Careers
CareersMid/Senior QA Manager
We are seeking an experienced Quality Assurance Manager or Senior Quality Assurance Manager to own and drive our quality management system as we scale our SaMD platform across global markets. This is a critical role with leadership potential for someone who thrives in a fast-paced, high-growth environment and is passionate about building quality into the fabric of a regulated medical device company.
- Develop and execute strategy and plans for continuous improvement of QMS efficiency and effectiveness
- Maintain the company's quality system in accordance with applicable medical device regulations and standards, including ISO 13485:2016
- Act as the Management Representative in accordance with ISO 13485:2016
- Provide QA leadership, guidance, and oversight to cross-functional teams including product, engineering, systems, and Verification and Validation (V&V) teams
- Build and maintain regular lines of communication across teams to promote quality awareness, regulatory compliance, and harmonisation of quality processes
- Own and monitor key quality functions including change control, supplier evaluation, CAPA, complaints management, post-market surveillance, training, and trend analysis
- Support external and internal audits, including interactions with notified bodies, TGA, FDA, and other relevant regulatory authorities
Contribute to post-market activities as required
Manager vs Senior Manager
For the Manager level, we are looking for someone with solid foundational QMS experience who is ready to take ownership of a quality function in a growing company.
For the Senior Manager level, we are additionally looking for someone with a track record of building and leading QA teams in a regulated medical device environment, and the ability to contribute strategically, from shaping QMS direction to supporting global market access goals.
- Both roles are fundamentally hands-on. We are looking for someone who is equally comfortable setting quality strategy and rolling up their sleeves to get things done.
Essential Skills
- Minimum 4 years of experience in a quality assurance role within the medical device industry
- Demonstrated experience maintaining and managing a Quality Management System (QMS) in accordance with ISO 13485
- Proven experience planning and conducting internal audits and managing CAPAs end-to-end
- Excellent written and verbal communication skills with the ability to engage effectively across all levels, from engineering teams to senior management and external regulators
- Strong organisational skills with the ability to manage multiple priorities and deliver under pressure
- Bachelor's degree or higher in a relevant field (engineering, science, or related discipline)
Desirable Skills
- Experience with MDSAP or equivalent multi-market audit programmes
- Experience working with Software as a Medical Device (SaMD) or AI/ML-enabled medical devices
- Familiarity with IEC 62304
- Strong working knowledge of applicable medical device regulations including EU MDR, FDA 21 CFR Part 820 / QMSR, or TGA requirements