Product Quality Assurance Manager

4 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $180,000 - $200,000
Job Description

We are seeking an experienced leader to oversee the product quality process, focusing on improving the performance of our on-market molecular diagnostic products.

The Product Quality Assurance Manager is responsible for ensuring the highest level of quality in all aspects of product development and support. Key responsibilities include:

  • Leading and enhancing the product quality process across the company
  • 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

Required Skills and Qualifications

To be successful in this role, you will need:

  • 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

Benefits

We offer a competitive salary commensurate with experience and a dynamic work environment that values diversity and equal employment opportunities.

Others

If you're passionate about making a difference in healthcare and meet the qualifications, we encourage you to apply with your cover letter and CV.

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