Quality Assurance Specialist

3 days ago

Sydney, New South Wales, Australia beBeeCompliance Full time $120,000 - $130,000
Job Title: Quality Assurance Specialist

Seeking an experienced Quality Assurance specialist to lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates. As a key member of the team, you will play a crucial role in ensuring compliance with regulatory standards and the global quality management system.

Responsibilities:
  • Lead internal audits, manage CAPAs, NCs, and quality records.
  • Conduct validation activities for custom-manufactured products at our Sydney facility.
  • Collaborate with internal teams and corporate stakeholders across the globe.
  • Train and support teams on quality and regulatory matters.
Requirements:
  • A solid understanding of ISO 13485 and quality systems.
  • Knowledge of internal auditing, CAPA, and validation processes.
  • Confidence, detail-orientation, and self-motivation.
  • Effective communication with stakeholders at all levels.
  • At least 3 years' experience in a QA/RA role, preferably in medical devices.

This is an exciting opportunity to contribute to improving lives through advanced hearing solutions.

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