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Quality Assurance Professional

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Sydney, New South Wales, Australia beBeeCompliance Full time $90,000 - $120,000
Job Description

We are seeking an expert to support our ANZ operations, ensuring compliance with regulatory standards and global quality management system.

As a Quality Assurance Associate, you will lead day-to-day QA functions for Australia, New Zealand, and affiliates, supporting compliance with ISO13485 and local regulatory standards. You will act as the local Subject Matter Expert for quality processes and risk assessments, conducting internal audits and managing CAPAs, NCs, and quality records.

Key Qualifications
  • A solid understanding of ISO 13485 and quality systems
  • Knowledge of internal auditing, CAPA, and validation processes
  • Confidence, detail-orientation, self-motivation, effective communication skills, and 3+ years' experience in a QA/RA role, ideally in medical devices