Global Medical Device company is looking for a Quality Assurance Associate support the implementation and maintenance of the company’s Quality Management System to ensure compliance with Australian regulations and international quality standards.

This role plays a critical part in ensuring that products meet regulatory requirements and customer expectations by maintaining high standards of quality and compliance.

Responsibilities include:

Assist in the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO 13485, TGA, FDA, and other relevant regulatory requirements.

Support the document control process, including reviewing, updating, and maintaining quality records.

Conduct internal audits to assess compliance with company policies, procedures, and regulatory standards.

Assist in supplier quality management, including supplier audits and qualification.

Support product quality reviews and post-market surveillance activities.

Participate in risk management activities, including identifying potential quality risks and implementing mitigation strategies.

Assist in complaint handling, non-conformance investigations, and corrective and preventive action (CAPA) processes.

Maintain accurate documentation and reporting to ensure traceability and regulatory adherence.

Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality standards are upheld.

This is a great opportunity for an experienced QA Specialist to join a growing and high performing team.

Salary negotiable on experience. Hybrid work environment also available.

For a confidential discussion, please contact Jenny on 0407 743 774.