KNOWLEDGE

• Good understanding of Quality Management Systems framework and principles.
• MDSAP regulatory framework and effect on AU/NZ regulatory authorities regulations particular to medical devices.
• Knowledge of processes and requirements of regulatory authorities in Australia and New Zealand.

EXPERIENCE

• 3 years working in Quality function in a similar position.

QUALIFICATIONS

• Certified ISO 9001, ISO 13485, FDA or MDSAP skills or Internal Auditor (desired).
• Certified QMS Representative (desired).
• Certified Lean Manufacturing/Six Sigma skills (desired).

SKILLS AND ABILITIES

• Analytical thinking and focused on problem solving.
• Advanced Microsoft Excel skills.
• Ability to work autonomously.
• High attention to detail and responsibility for performed actions, decisions.
• Strong prioritisation, time management and organisational skills.
• Strong verbal and written communication skills.
• Customer Focused attitude.

• Overall responsible for quality and regulatory compliance by applying and maintaining processes in Demant Operations (production and distribution) and Wholesale functions for ANZ.
• Coordination of quality related topics in Wholesale and Operations by close cooperation with Demant Quality and Regulatory Compliance