Job Description
About the role
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Proton Intelligence is seeking a senior, hands‐on Director of Quality to build, implement and lead a fit‐for‐purpose, ISO *****-compliant quality management system as our continuous potassium monitoring products advance through clinical development and toward commercialisation.
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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.
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WHAT YOU'LL DO
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Own Proton's quality strategy, QMS roadmap and operating cadence, including the critical path toward ISO ***** certification.
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Assess current quality processes and documentation, identify compliance gaps and lead a proportionate, risk‐based remediation plan aligned with company milestones.
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Establish practical quality governance, process ownership, review forums, decision rights, escalation pathways and management review.
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Implement and administer an effective electronic quality management system and build robust document‐control processes, SOPs, work instructions, templates, forms, registers and controlled records.
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Establish and operate fit‐for‐purpose design controls integrated with product development, including the Design History File, traceability, verification, validation and design transfer.
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Partner with Technical and Regulatory teams to keep requirements, risks, standards, claims,



changes and submission evidence coherent and ready for review.
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Mature core QMS processes including supplier quality, training, nonconformance, deviations, CAPA, equipment and calibration controls, internal audits and quality metrics.
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Support Clinical Operations with appropriate quality oversight of study documentation, vendors, training, deviations, data integrity and inspection readiness.
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Investigate quality issues to root cause, ensure corrective and preventive actions are effective, and use trends to improve both the QMS and underlying operations.
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Deliver practical quality training, coach colleagues, manage specialist providers as needed and build the plan for future quality‐team capacity as Proton scales.
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WHAT WE'RE LOOKING FOR
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10+ years of progressively responsible quality experience in medical devices, diagnostics, connected health or a related regulated‐product environment.
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Demonstrated success building, materially remediating or scaling a medical‐device QMS and leading an organisation through ISO ***** certification or recertification.
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Deep applied knowledge of ISO *****, document control, design controls, risk management, supplier quality, training, nonconformance, CAPA, audits and management review.
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Hands‐on experience implementing and administering an electronic quality management system.
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Sound judgement in assessing imperfect legacy documentation and compliance debt, making proportionate risk‐based decisions and sequencing remediation without paralysing product development.
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Solid change‐leadership, coaching and influencing skills, including experience helping technically capable teams adopt consistent regulated ways of working.
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Ability to work across hardware, software and data, clinical, regulatory, operations, manufacturing and executive stakeholders.
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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.
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A degree in engineering, life sciences, quality or a related discipline is required; advanced quality or regulatory certification is preferred.
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WHAT SUCCESS LOOKS LIKE
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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 ***** certification.
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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.
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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.
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📌 Director Of Quality (Victoria)
🏢 Proton Intelligence
📍 Victoria