Quality Assurance Regulatory Compliance coordinator

#LI-TS1 #LI-HYBID

Role Purpose 

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

Key Accountabilities

Operations Quality:

• Assuring compliance with production and distribution standards established in Demant.
• Overseeing production and distribution outgoing quality incl. setting up quality KPIs, creating and maintaining measurement and reporting systems, analysing quality data and coordinating improvement, preventive or corrective actions.
• Coordinating local implementation of global changes to production or distribution processes

Quality Assurance/Compliance

• Assuring organization’s compliance with Demant standards following established Quality Management System requirements.

• Creating, maintaining and improving organization’s Quality Management System (QMS Responsible).
• Preparing and coordinating internal audits and hosting external audits.

Regulatory Compliance

• Assuring organization’s compliance with regulatory standards in Demant.
• Coordinating cooperation with relevant regulatory authorities in Australia and New Zealand incl. registering new devices and reporting on released legislative changes impact on the business.

Knowledge

• Good understanding of Quality Management in Operations and Quality Management Systems framework and principles.
• 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).

 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.