Director of Quality

About the role

Proton Intelligence is seeking a senior, hands-on Director of Quality to build, implement and lead a fit-for-purpose, ISO 13485-compliant quality management system as our continuous potassium monitoring products advance through clinical development and toward commercialisation.

This is a foundational leadership role based at our R&D Centre in Clayton, Victoria. You will partner closely with Technical, Clinical, Regulatory, Operations and Executive leaders to make quality a practical part of how the company works. The right person will be comfortable setting strategy, doing the detailed work, coaching a growing team and helping colleagues adopt disciplined regulated-development practices.

WHAT YOU'LL DO

• Own Proton's quality strategy, QMS roadmap and operating cadence, including the critical path toward ISO 13485 certification.

• Assess current quality processes and documentation, identify compliance gaps and lead a proportionate, risk-based remediation plan aligned with company milestones.

• Establish practical quality governance, process ownership, review forums, decision rights, escalation pathways and management review.

• Implement and administer an effective electronic quality management system and build robust document-control processes, SOPs, work instructions, templates, forms, registers and controlled records.

• Establish and operate fit-for-purpose design controls integrated with product development, including the Design History File, traceability, verification, validation and design transfer.

• Partner with Technical and Regulatory teams to keep requirements, risks, standards, claims, changes and submission evidence coherent and ready for review.

• Mature core QMS processes including supplier quality, training, nonconformance, deviations, CAPA, equipment and calibration controls, internal audits and quality metrics.

• Support Clinical Operations with appropriate quality oversight of study documentation, vendors, training, deviations, data integrity and inspection readiness.

• Investigate quality issues to root cause, ensure corrective and preventive actions are effective, and use trends to improve both the QMS and underlying operations.

• Deliver practical quality training, coach colleagues, manage specialist providers as needed and build the plan for future quality-team capacity as Proton scales.

WHAT WE'RE LOOKING FOR

• 10+ years of progressively responsible quality experience in medical devices, diagnostics, connected health or a related regulated-product environment.

• Demonstrated success building, materially remediating or scaling a medical-device QMS and leading an organisation through ISO 13485 certification or recertification.

• Deep applied knowledge of ISO 13485, document control, design controls, risk management, supplier quality, training, nonconformance, CAPA, audits and management review.

• Hands-on experience implementing and administering an electronic quality management system.

• Sound judgement in assessing imperfect legacy documentation and compliance debt, making proportionate risk-based decisions and sequencing remediation without paralysing product development.

• Strong change-leadership, coaching and influencing skills, including experience helping technically capable teams adopt consistent regulated ways of working.

• Ability to work across hardware, software and data, clinical, regulatory, operations, manufacturing and executive stakeholders.

• Excellent written and verbal communication skills and a willingness to operate as a hands-on first quality leader while building durable systems and developing others.

• A degree in engineering, life sciences, quality or a related discipline is required; advanced quality or regulatory certification is preferred.

WHAT SUCCESS LOOKS LIKE

• In your first 90 days, you will assess Proton's current quality system and establish an agreed, risk-based roadmap for closing critical gaps and progressing toward ISO 13485 certification.

• During your first year, you will embed the electronic quality system and core QMS processes, strengthen design controls and quality records, establish a current and traceable Design History File, and close or formally control the highest-risk legacy gaps.

• Longer term, you will mature the system toward audit readiness, build sustainable quality capability across the company and reduce dependence on the Quality lead for routine compliance.