Senior Director, Quality & ISO 13485 QMS

Proton Intelligence; Melbourne; Presencial; AUD 240.000 - 300.000; Jornada completa

Descripción de la vacante

Proton Intelligence seeks a senior, hands-on Director of Quality to build and lead an ISO 13485‑compliant QMS as our potassium monitoring products advance through clinical development toward commercialization. Based at our R&D Centre in Clayton, Victoria, you will partner across Technical, Regulatory, Clinical, Operations and Executive teams to embed disciplined quality practices.

You will set strategy, perform the detailed work, coach a growing team and ensure readiness for audits, supplier

Formación

• 10+ years quality leadership in regulated medical devices.
• Proven ISO 13485 implementation or certification leadership.
• Deep knowledge of ISO 13485, document control, design controls.
• Hands-on experience with electronic QMS.
• Ability to lead cross-functional teams across hardware/software.

Responsabilidades

• Own quality strategy and QMS roadmap toward ISO 13485.
• Identify gaps and implement risk-based remediation.
• Establish governance, ownership, and review processes.
• Implement and maintain an electronic QMS and document control.
• Manage design controls with Design History File and traceability.
• Coordinate with Technical, Regulatory, Operations and Exec leaders.
• Lead supplier quality, CAPA, audits, training, metrics.
• Provide quality oversight of study documentation and vendors.
• Investigate issues, root cause, and implement CAPA.
• Deliver quality training and build capacity for scale.

Conocimientos

Quality leadership

ISO 13485 knowledge

QMS implementation

Regulatory compliance

Cross-functional collaboration

Document control

Educación

Engineering/Life sciences degree

Quality/regulatory certification

Herramientas

QMS software (e.g., MasterControl)

Descripción del empleo

Proton Intelligence seeks a senior, hands-on Director of Quality to build and lead an ISO 13485‑compliant QMS as our potassium monitoring products advance through clinical development toward commercialization. Based at our R&D Centre in Clayton, Victoria, you will partner across Technical, Regulatory, Clinical, Operations and Executive teams to embed disciplined quality practices.

You will set strategy, perform the detailed work, coach a growing team and ensure readiness for audits, supplier