ANZ Quality & Regulatory Leader — Drive Compliance & QMS

Sonova Group; Sydney; Presencial; AUD 150.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Global leader in hearing healthcare

Influence across ANZ business

Exposure to regional and global teams

Collaborative culture

Professional development opportunities

Descripción de la vacante

Sonova ANZ is seeking an experienced Quality & Regulatory Manager ANZ to lead our local quality management system and regulatory compliance across Australia and New Zealand. You will partner with stakeholders to drive continuous improvement, ensure audit readiness, and uphold high quality across products and processes.

Join a global leader in hearing healthcare, influencing regional quality strategies and collaborating with regional/global teams to deliver patient‑focused outcomes.

Formación

• Degree in Engineering, Manufacturing, or related field is required.
• Experience in Quality Management, Regulatory Affairs, Medical Devices, or regulated industry.
• Experience in GMP environments and audit processes.
• Strong QMS knowledge and audit capability; expertise in quality improvements.

Responsabilidades

• Lead and maintain local QMS aligning with global requirements.
• Drive compliance with ISO 13485, ISO 9001, MDSAP and related standards.
• Manage QA operations, monitor processes and improvement opportunities.
• Oversee product release and qualification activities for compliance.
• Lead customer complaint investigations and corrective actions.
• Analyze quality trends and implement preventative actions.
• Collaborate with procurement and supplier quality teams.
• Serve as main contact for regulatory authorities and auditors.
• Plan and lead internal and external audits, ensuring readiness.
• Provide quality reporting and recommendations to leadership.
• Support quality/process improvement initiatives with analytics.

Conocimientos

Quality management

Regulatory affairs

GMP experience

Auditing

Stakeholder management

Problem solving

Educación

Degree in Engineering/Manufacturing or related

Descripción del empleo

Sonova ANZ is seeking an experienced Quality & Regulatory Manager ANZ to lead our local quality management system and regulatory compliance across Australia and New Zealand. You will partner with stakeholders to drive continuous improvement, ensure audit readiness, and uphold high quality across products and processes.

Join a global leader in hearing healthcare, influencing regional quality strategies and collaborating with regional/global teams to deliver patient‑focused outcomes.