Quality Support Officer

at  Olympus Australia

Our Quality Assurance and Regulatory Affairs (QARA) team are on the hunt for a Quality Support Officer to join the team.
The QARA Support Officer, guided by the Complaints Resolution Lead, will support various Quality, Regulatory, and Customer initiatives. This role involves assisting the wider Quality and Regulatory team to support Olympus customers, manufacturers, and internal stakeholders, primarily focusing on product complaints, Medical Device Reporting (MDR), and Field Corrective Action (FCA) activities.

Key Responsibilities:

• Post Market Compliance: Handle product complaints, MDRs, and FCAs in line with ISO9001, ISO14001, regulatory bodies, and Olympus requirements.
• Product Expertise: Serve as a product expert to support post-market activities.
• Customer Advocacy: Resolve product concerns by clarifying complaints, identifying problems, and ensuring resolution.
• MDR Process Coordination: Review, evaluate, and handle MDR reporting, including incident reports and follow-up regulatory reporting.
• Complaint and FCA Management: Ensure timely closure of product complaints and FCA cases, coordinate returns, financial credits, follow-up requests, and customer responses.
• Record Keeping: Maintain records of customer inquiries, comments, and complaints using Salesforce and GCHS.
• Open Case Management: Monitor and manage open return orders and cases within Salesforce and GCHS, escalating as needed.
• Team Support: Assist team members and support QARA improvement initiatives and projects.

• Post Market Compliance: Handle product complaints, MDRs, and FCAs in line with ISO9001, ISO14001, regulatory bodies, and Olympus requirements.
• Product Expertise: Serve as a product expert to support post-market activities.
• Customer Advocacy: Resolve product concerns by clarifying complaints, identifying problems, and ensuring resolution.
• MDR Process Coordination: Review, evaluate, and handle MDR reporting, including incident reports and follow-up regulatory reporting.
• Complaint and FCA Management: Ensure timely closure of product complaints and FCA cases, coordinate returns, financial credits, follow-up requests, and customer responses.
• Record Keeping: Maintain records of customer inquiries, comments, and complaints using Salesforce and GCHS.
• Open Case Management: Monitor and manage open return orders and cases within Salesforce and GCHS, escalating as needed.
• Team Support: Assist team members and support QARA improvement initiatives and projects