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Chief Quality Strategist

2 weeks ago

Melbourne, Victoria, Australia beBeeQuality Full time $150,000 - $200,000

About PolyNovo, a global leader in medical device innovation, we foster a culture of excellence and quality.

We seek a strategic leader to oversee our Quality Management System (QMS) aligned with ISO 13485 and FDA regulations.

  • Lead and manage the Quality Assurance, Post Market Surveillance, and Quality Control teams to ensure regulatory compliance.
  • Review and improve the QMS to reflect all processes involved in designing, developing, manufacturing, and distributing medical devices.
Key Responsibilities:
  • Develop strategies to mitigate risks to device safety, performance, and efficacy.
  • Host regulatory audits, review and update the annual audit schedule, and assign tasks to meet QMS requirements.
  • Work closely with R&D, Regulatory Affairs, Clinical Research, and Production personnel to ensure Design History Files are created for all products.
  • Maintain controlled documents, Batch Process Records, QC release testing, raw material/product reports, and labelling protocols.
  • Ensure the QMS Training Matrix and documentation requirements are regularly reviewed and updated.
  • Manage the Change Control process, provide oversight on CAPAs and investigations, and report on QMS suitability and effectiveness.