Senior Quality Operations Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeCompliance Full time $90,000 - $110,000
Quality Assurance Role OverviewWe are seeking a skilled Quality Assurance Associate to join our growing Healthcare division. As the Senior Quality Assurance Associate, you will play a critical role in ensuring the integrity and compliance of healthcare operations.This position provides day-to-day quality support across warehouse and operational functions, ensuring adherence to client-specific requirements, regulatory standards, and internal procedures.The ideal candidate will have solid knowledge of ISO 13485, with practical experience applying its principles in a healthcare, medical device, or pharmaceutical environment.Familiarity with TGA regulations, PIC/S Code of GMP, and GWP is highly advantageous.Prior experience working in or with a logistics site is also beneficial.Responsibilities:
  • Quality Oversight & Compliance: Ensure all warehouse and operational activities comply with internal procedures, client requirements, and applicable regulatory standards.
  • Issue Management & Resolution: Timely investigation, documentation, and resolution of Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Change Controls.
  • Customer & Stakeholder Engagement: Provide clear and professional communication with customers regarding Quality matters.
  • Process & System Integrity: Oversight of SAS release, controlled destruction, and return to vendor sessions.
  • Training & Documentation: Ensure training records and labelling processes are compliant and current.
  • Performance Monitoring: Track and trend Quality KPIs and metrics.
Requirements:
  • Solid knowledge of ISO 13485.
  • Practical experience applying ISO 13485 principles in a healthcare or pharmaceutical environment.
  • Familiarity with TGA regulations and PIC/S Code of GMP.
  • Basic understanding of Supply Chain Management and Integrated Logistics.
Benefits:

We offer a dynamic work environment where you can grow your skills and expertise. Our company values diversity and inclusion, providing opportunities for personal and professional development.

About Us:

We are a leading provider of integrated logistics solutions, delivering innovative services that meet the evolving needs of our customers.

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