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Strategic Quality Leader

2 weeks ago

Melbourne, Victoria, Australia beBeeQuality Full time $150,000 - $200,000
Strategic Quality Leadership Role

We are seeking an experienced strategic leader to join our team as a Vice President of Quality Affairs. This key role will oversee maintaining and continually enhancing our Quality Management System (QMS) aligned with ISO 13485 and FDA regulations.

The successful candidate will provide regular reports to senior management on QMS performance, drive a culture of quality, compliance, and continuous improvement, and lead and mentor our talented Quality Assurance, Quality Control, and Post-Market Surveillance teams.

Key Responsibilities:
  • Lead and manage the Quality Assurance, Post Market Surveillance, and Quality Control teams.
  • Review and improve the QMS to reflect all processes involved in designing, developing, manufacturing, and distributing medical devices.
  • Liaise with staff to 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.