Quality Specialist - Brisbane City, Australia - Brunel GmbH

Description

• 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