Quality Specialist

1 month ago


Brisbane, Australia Brunel Full time
Administration & Oversight: Manage QMS processes including deviations, non-conformance reporting, CAPA, change management, supplier qualifications, validation, and risk management Regulatory Compliance: Ensure compliance with MDR (2020), ISO 13485, FDA's 21 CFR Part 820, and other relevant standards Quality Assurance: Monitor manufacturing performance, batch reviews, and post-market surveillance Support & Collaboration: Provide guidance for design, development, and product launch, collaborate with suppliers, and support continuous improvement Documentation & Training: Establish and update procedures, approve documentation, and conduct staff training Vendor Management: Qualify new vendors, maintain agreements, and review vendor performance Regulatory Support: Assist with lifecycle management of medical devices and maintain regulatory compliance Audit & Accreditation: Support internal audits, participate in audit activities, and maintain ISO accreditation and regulatory approvals
  • Administration & Oversight: Manage QMS processes including deviations, non-conformance reporting, CAPA, change management, supplier qualifications, validation, and risk management
  • Regulatory Compliance: Ensure compliance with MDR (2020), ISO 13485, FDA's 21 CFR Part 820, and other relevant standards
  • Quality Assurance: Monitor manufacturing performance, batch reviews, and post-market surveillance
  • Support & Collaboration: Provide guidance for design, development, and product launch, collaborate with suppliers, and support continuous improvement
  • Documentation & Training: Establish and update procedures, approve documentation, and conduct staff training
  • Vendor Management: Qualify new vendors, maintain agreements, and review vendor performance
  • Regulatory Support: Assist with lifecycle management of medical devices and maintain regulatory compliance
  • Audit & Accreditation: Support internal audits, participate in audit activities, and maintain ISO accreditation and regulatory approvals
  • Opportunity to work in a fast-paced environment
  • Great team culture
  • Wage dependent on experience (approx.100,000)

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