Quality Assurance Regulatory Compliance coordinator

About Demant:

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Demant is a world-leading hearing healthcare group that offers solutions and services to help people with hearing loss connect and communicate with the world around them. For more than a century, the Demant Group has played a vital part in developing innovative technologies and know-how to help improve people’s health and hearing. In every aspect, from hearing devices, hearing implants and diagnostic equipment to hearing care all over the world, Demant is active and engaged. A growing business in intelligent audio solutions for gaming and office communication is also a significant part of the Group.

The Demant Group operates in a global market with companies in more than 30 countries, employs approx. 17,500 people globally. Our products are sold in more than 130 countries where we create life-changing differences through hearing health.

Role Purpose (Why does the role exist?)

• 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.

Key Accountabilities

Operations Quality:

• Overseeing production and distribution outgoing quality incl. setting up quality KPIs, creating and maintaining measurement and reporting systems, analysing quality data and coordinating improvement activities or resolving nonconformities in relation to product or processes quality.
• Assuring compliance with production and distribution standards established in Demant.
• Calling in and coordinating production stop/recall procedures or escalations in coordination with Demant Quality and internal/external stakeholders.
• Aligning and knowledge sharing with other Operations sites in Demant.
• Coordinating local implementation of global changes to production or distribution processes (Change Notifications) incl. ensuring trainings are documented and training records maintained.

Quality Assurance/Compliance

• Assuring Wholesale/Operations compliance with Demant standards following established requirements (HI QMS).

• Supervising and coordinating corrective/preventive actions within organization.
• Building quality awareness, mindset among employees.
• Holding local Quality Management System representative role on behalf of Demant Quality.
• Coordination of activities related to maintaining and improving organization’s Quality Management System (QMS Responsible).
• Coordinating local implementation of global changes to Demant’s Quality Management System incl. ensuring trainings are documented and training records maintained.
• Preparing and coordinating internal audits and hosting external audits.
•  Liaising with Demant Quality to ensure all QA aspects are maintained and corrected where necessary.

Regulatory Compliance

• Assuring organization’s compliance with regulatory standards in Demant.
• Pro-active following escalation model in case of any adverse events.
• Responsible for registering new devices with the relevant regulatory authorities in ANZ (i.e. TGA, Medsafe).
• Review and analysis of released TGA/Medsafe regulations and legislative changes and reporting on the effect on the business.
• Coordinating responses to consultation papers from regulatory authorities.

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.