QA Specialist

1 day ago

Sydney, New South Wales, Australia beBeeQuality Full time $90,000 - $120,000
Job Title: Quality Assurance

We are seeking a Quality Assurance expert to join our team and play a crucial role in ensuring compliance with regulatory standards and our global quality management system.

About the Role:

This is an exciting opportunity for a qualified professional to lead day-to-day QA functions, support compliance with ISO 13485 and local regulatory standards, and act as the local Subject Matter Expert for quality processes and risk assessments.

Key Responsibilities:
  • Lead day-to-day QA functions for Australia, New Zealand, and affiliates.
  • Support compliance with ISO 13485 and local regulatory standards.
  • Act as the local Subject Matter Expert for quality processes and risk assessments.
  • Conduct internal audits and manage CAPAs, NCs, and quality records.
  • Drive validation activities for custom-manufactured products at our facility.
  • Collaborate with internal teams and corporate stakeholders across the globe.
  • Train and support teams on quality and regulatory matters.
  • Represent the business in local QA meetings and interactions with regulatory bodies.
Requirements:
  • Solid understanding of ISO 13485 and quality systems.
  • Knowledge of internal auditing, CAPA, and validation processes.
  • Confidence, detail-orientation, and self-motivation.
  • Effective communication skills with stakeholders at all levels.
  • 3+ years' experience in a QA role, ideally in medical devices.
  • Natural problem-solving skills and ability to thrive in a process-driven environment.
What We Offer:

We offer a competitive compensation package, comprehensive training, and opportunities for growth and development in a dynamic and supportive work environment.

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