Quality Assurance Leader

2 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time $120,000 - $140,000
Job Opportunity

We are seeking a solution-driven Quality Assurance Professional to join our Regulatory and Quality team.

This standalone role leads the development, implementation, and maintenance of the quality management system, ensuring compliance with ISO 13485 standards.

The role oversees quality controls and process checks to deliver high-quality products that support better healthcare outcomes for patients worldwide.

Key Responsibilities:
  • Develop, implement, and continually improve the Quality Management System (QMS) in alignment with regulatory requirements.
  • Act as the subject matter expert for ISO 13485, providing quality strategic guidance across the business.
  • Coordinate with cross-functional teams to define and maintain QMS processes for their departments.
  • Partner with the Global Regulatory and Quality Manager to ensure product development meets quality and regulatory standards.
  • Liaise with Production and QC to support compliance in manufacturing, quality control, and documentation practices.
  • Manage and improve the electronic Quality Management System (eQMS), ensuring records are maintained and accessible.
  • Lead internal and external audits, including planning, hosting, and timely closure of audit findings.
  • Coordinate supplier audits and monitor supplier quality performance in collaboration with Procurement.
  • Oversee nonconformance and CAPA processes to ensure timely resolution and drive continual improvement.
  • Monitor and report on QMS performance metrics, providing actionable insights for process enhancement.
  • Analyze quality data, including complaints and audit trends, to identify areas for improvement.
  • Support post-market surveillance activities and ensure findings are fed back into the QMS.
  • Evaluate integration of risk management activities in line with ISO 14971 throughout product and process lifecycles.
  • Contribute to setting and reviewing quality objectives and participate in annual management reviews.
  • Coordinate training and competency programs to ensure staff compliance with QMS requirements.
Requirements:
  • Experience in managing or implementing quality systems for regulated medical products.
  • Knowledge of ISO 13485 and relevant regulatory frameworks.
  • Internal and external audit experience, including regulatory and certification body inspections.
  • CAPA, nonconformance handling, and supplier quality management expertise.
  • Document control, change management, and training systems knowledge.
  • Strong analytical thinking and a process-driven, solution-oriented mindset.
  • Clear, confident written and verbal communication skills.
  • Able to work independently and collaboratively within cross-functional teams.

You will also hold a bachelor's degree in science, engineering, or a related field (a master's or PhD is advantageous). Experience in the diagnostics or life sciences sectors will be highly regarded.

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