About Proton Intelligence Inc.
Proton Intelligence is developing subcutaneously implantable sensors intended to improve the management of chronic kidney disease and heart failure. Our lead product is a continuous potassium monitoring platform designed to give clinicians and patients earlier, more actionable visibility into changes in potassium levels.
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.
