Director of Quality

Proton Intelligence; City of Monash; Presencial; AUD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Proton Intelligence, based in Clayton, Victoria, seeks a senior, hands-on Director of Quality to build and lead a fit-for-purpose QMS aligned with ISO 13485 as it advances its continuous potassium monitoring products through clinical development toward commercialisation.

You will partner with Technical, Regulatory, Clinical, Operations and Executive leaders to embed disciplined regulated-development practices, coach a growing team, and drive audit readiness.

Formación

• 10+ years of quality experience in medical devices.
• Experience in ISO 13485 certification or recertification.
• Hands-on expertise implementing an electronic QMS.
• Strong change leadership and cross-functional collaboration.

Responsabilidades

• Own quality strategy and QMS roadmap toward ISO 13485.
• Identify gaps and lead risk-based remediation.
• Establish governance, reviews, and escalation paths.
• Implement and maintain an electronic QMS and documents.
• Develop design controls with DHF and traceability.
• Collaborate with Technical, Regulatory, Operations and Exec teams.
• Lead audits, CAPA, training, and supplier quality.
• Prepare for inspections and ensure data integrity.
• Mentor the quality team and scale capability.
• Drive disciplined regulated-development practices.

Conocimientos

Quality leadership

ISO 13485 knowledge

QMS implementation

Regulatory compliance

Document control

Design controls

Risk management

CAPA & audits

Cross-functional collaboration

Hands-on quality

Educación

Engineering degree

Life sciences degree

Quality/regulatory certification preferred

Herramientas

Electronic QMS

Document control software

CAPA tools

Descripción del empleo

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.