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Product Quality and Compliance Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time $100,000 - $125,000

Are you a leader who thrives in regulated environments and is passionate about product quality?

About the Role

We seek an experienced Product Care and Quality Team Lead to oversee our product care process, focusing on improving the performance of our molecular diagnostic products.

  • Leading and enhancing the product care process across the organization
  • Reviewing complaints and technical support data to identify issues
  • Conducting investigations and root cause analysis
  • Coordinating lab testing to determine defect sources or user errors
  • Preparing reports and recommending corrective actions
  • Collaborating with cross-functional teams to resolve issues
  • Monitoring trends and reporting on product performance
  • Improving training materials and documentation
  • Integrating lessons learned into design and risk management
  • Participating in quality system activities and audits
  • Supporting senior leadership and other departments as needed
Required Qualifications and Experience

To succeed in this role, you will need:

  • A minimum 5+ years of experience in Molecular Diagnostics, with knowledge of regulations, processes, products, and technologies
  • Experience in R&D, manufacturing, or post-market support within Molecular Diagnostics
  • Strong knowledge of IVD regulations and technologies such as PCR, methylation, or molecular biology
  • Experience managing product investigations in regulated environments
  • Understanding of ISO 13485 and related standards
  • Excellent communication and teamwork skills
  • Strong project and stakeholder management skills
  • Bachelor's degree in Molecular Biology, Biotechnology, Biomedical Science, or related field
  • Familiarity with CAPA, post-market surveillance, and complaint handling systems
  • Proficiency with Microsoft Office and quality documentation systems

We are seeking a highly skilled professional who can drive quality and excellence in our product care process. If you have a passion for leading high-performing teams and driving results in a fast-paced environment, we encourage you to apply.