Quality Assurance Regulatory Compliance Coordinator

4 hours ago

Australia Demant Full time

#LI-TS1 #LI-HYBID

**Role Purpose**
- 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.

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