Quality Assurance Professional

5 days ago


Sydney, New South Wales, Australia beBeeQuality Full time $90,000 - $120,000

Quality Assurance Role

We are seeking a highly skilled and motivated Quality Assurance professional to join our team. This role is crucial in ensuring compliance with regulatory standards and quality management systems.

About the Job

  • This position will lead day-to-day QA functions, including internal audits, CAPAs, NCs, and quality records.
  • The ideal candidate will have strong knowledge of ISO 13485 and quality systems, as well as experience in validation processes.
  • They will be confident, detail-oriented, and self-motivated, with effective communication skills and the ability to work collaboratively with internal teams.

Key Responsibilities:

  • Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
  • Support compliance with regulatory standards and GN's global quality management system.
  • 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 Sydney 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/RA meetings and interactions with TGA and other bodies.
  • Be a key player in a high-performing, values-led QA/RA team.

Requirements:

  • Strong understanding of ISO 13485 and quality systems.
  • Knowledge of internal auditing, CAPA, and validation processes.
  • Confident, detail-oriented, and self-motivated individual.
  • Effective communication skills with stakeholders at all levels.
  • Minimum 3 years' experience in a QA/RA role, preferably in medical devices.
  • Natural problem-solver who thrives in a process-driven environment.

What We Offer:

  • A dynamic and supportive team environment.
  • Ongoing training and development opportunities.
  • A competitive salary and benefits package.
  • The chance to make a real difference in the quality of our products and services.


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