Hearing Healthcare Quality Compliance Specialist

2 days ago

Australia beBeeCompliance Full time $100,000 - $120,000
About the Role

The Quality Assurance Regulatory Compliance Coordinator plays a pivotal part in driving quality excellence across Wholesale and Operations.

This involves close collaboration with Demant's Quality and Regulatory Compliance teams to ensure seamless coordination of quality-related topics.

Key Responsibilities
  • Oversight of production and distribution quality, including setting up quality KPIs, creating measurement and reporting systems, analyzing quality data, and coordinating improvement activities or resolving nonconformities.
  • Ensuring compliance with established production and distribution standards.
  • Coordination of production stop/recall procedures or escalations in coordination with Demant Quality and internal/external stakeholders.
  • Alignment and sharing of knowledge with other Operations sites within Demant.
  • Implementation of global changes to production or distribution processes (Change Notifications) while ensuring training records are maintained.
Quality Assurance/Compliance
  • Assurance of Wholesale/Operations compliance with Demant standards following established requirements (HI QMS).
  • Supervision and coordination of corrective/preventive actions within the organization.
  • Builing quality awareness and mindset among employees.
  • Representation of Demant Quality as local Quality Management System representative.
  • Coordination of activities related to maintaining and improving the organization's Quality Management System (QMS Responsible).
  • Implementation of global changes to Demant's Quality Management System while ensuring trainings are documented and training records maintained.
  • Preparation and coordination of internal audits and hosting external audits.
  • Liaising with Demant Quality to ensure all QA aspects are maintained and corrected where necessary.
Regulatory Compliance
  • Assurance of organization's compliance with regulatory standards in Demant.
  • Pro-active follow-up of escalation models in case of adverse events.
  • Registration of new devices with relevant regulatory authorities in ANZ (TGA, Medsafe).
  • Review and analysis of released TGA/Medsafe regulations and legislative changes, reporting on their effect on the business.
  • Coordination of responses to consultation papers from regulatory authorities.
Requirements

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 problem-solving focus.
  • Advanced Microsoft Excel skills.
  • Ability to work autonomously.
  • High attention to detail and responsibility for performed actions, decisions.
  • Strong prioritization, time management, and organizational skills.
  • Strong verbal and written communication skills.
  • Customer-focused attitude.

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