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.