QuantuMDx Group Limited
February 2015 — Present
• Compile and maintain Device Master Records in preparation for Regulatory submissions under 98/79/EC.
• Compile and maintain Device Risk Management Files
• Implement systems that facilitate productivity, improve processes and guarantee efficacy.
• Lead training sessions to ensure the understanding and compliance of ISO 13485 with all employees.
• Schedule, administer, prepare and conduct internal system audits and external vendor assurance audits as necessary.
• Maintenance of electronic Quality Management System, Q-Pulse. Including reviewing and authorising documents such as SOPs, COSHH, project plans.
• Identify, own and ensure CAPAs are completed on time.
• Keep up-to-date with and inform higher management of relevant Regulatory updates including assessing their impact on the company’s QMS.
• Promote the benefits of a quality system to all employees.