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Quality Assurance Regulatory Compliance coordinator

Australia
Nundah

 

#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.

 

About Demant

Demant is a world-leading hearing healthcare and technology group built on a heritage of care, health, and innovation since 1904. The Group offers innovative technologies, solutions, and expertise to help people hear better. In every aspect, from hearing care, hearing aids and hearing implants to diagnostic equipment and services and audio solutions, Demant is active and engaged. Headquartered in Denmark, the Group employs more than 21,000 people globally and is present with solutions in 130 countries where we create life-changing hearing health and high-end audio and video solutions. William Demant Foundation holds the majority of shares in Demant A/S, which is listed on Nasdaq Copenhagen and among the 25 most traded stocks.

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