Senior Quality Assurance Lead

6 days ago

Sydney, New South Wales, Australia beBeeCompliance Full time $150,000 - $180,000
Job Title: Senior Quality Assurance Lead

The primary goal of this position is to establish and maintain robust management systems that ensure compliance with regulatory frameworks across multiple industries.

The ideal candidate will have a proven track record of building strong relationships with cross-functional teams, ensuring timely registrations, and auditing processes to guarantee regulation compliance and quality best practices.

This role involves leading significant quality projects, creating and improving quality and business processes, and developing capability and process improvements for compliance and continuous improvement.

  • Collaborate with Factory Focus teams to drive current KPIs of Quality, Delivery, and Cost.
  • Lead new product introductions into manufacturing, involving XFT deliverables and phase transitions in collaboration with QA counterpart in XFT and QA/RA team.
  • Enhance quality systems to support manufacturing, including reviews across all areas of manufacturing and QA production support team to ensure consistency and standardization in ResMed QMS across various manufacturing business units and sites.
  • Mitigate risks of non-compliance and related business risks.
  • Provide quality/technical leadership through mentoring/coaching.
  • Maintain compliance to ResMed QMS; possess strong knowledge, application of, and compliance to FDA Quality System Regulations, GMP, and applicable ISO/regulatory standards.

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