Quality Assurance Specialist ( Medical Devices)

Quality Assurance Specialist (Medical Devices)

Ensure compliance with the ANZ Quality System in alignment with Core Dx Divisional Procedures and Good Distribution Practice for Medical Devices (GDPMD).

Serve as a Quality representative during internal and external audits.

Conduct Post-Market Surveillance (PMS) and Mandatory Problem Reporting in accordance with local and global regulations, including coordination of field actions / recalls and vigilance reporting to TGA and Medsafe.

Participate in the investigation of non-conformances and collaborate with relevant owners to develop effective CAPA plans.

Facilitate timely closure of CAPA actions with functional owners.

Manage local distributors in accordance with divisional requirements for Commercial Affiliate – Warehousing, Storage, and Distribution Processes.

Liaise with third-party warehouses on requirements and operational matters related to company products.

Oversee Purchasing and Supplier Control Processes in compliance with divisional procedures.

Coordinate and deploy divisional procedure training for relevant employees to ensure adherence to quality guidelines.

Collaborate with functional heads to develop and implement training plans, ensuring timely completion by respective employees.

Maintain the Site Master File and Regulatory Compliance Manual.

Execute document control activities, including periodic review of ANZ-controlled documents, to ensure alignment with divisional procedures.

Promote a culture of Quality and Compliance within the organization, providing guidance and support on quality-related matters across all functions.

Job Requirements

• Preferably candidate graduate from Bachelor’s Degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, Biomedical Science, Quality Management, or a related field.
• Preferably with QA experience in a pharmaceutical / medical devices company.
• Strong attention to detail, independent and accountable.
• Proficient in computer applications (Windows, MS Office).
• Good command of English, both written and spoken.
• Effective communication skills with internal and external stakeholders.

Application Information

For those who have what it takes, please apply online or send in your profile to : For more job opportunities, please visit

Application Questions

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