Quality Assurance Coordinator

CooperSurgical is a leading fertility and women’s healthcare company seeking a Quality Assurance Coordinator to support the Quality Department at Research Instruments in Falmouth, UK. The Quality Coordinator will be responsible for maintaining overall site compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements, managing quality documentation, and collaborating with various departments to resolve quality issues and improve processes.

Requirements

• Manage and maintain quality documents, records, and quality system procedures
• Gather data and report on KPIs to measure Quality Management System performance
• Identify Quality Management System-related non-conformances and identify trends that require escalation
• Maintain the Training Matrix and support the Quality Manager with the update of supplier status and Quality Agreements
• Assist with Internal Audits and maintain evidence of follow-up actions
• Support in preparation for and hosting of external audits
• Assist with Corrective and Preventive Action (CAPA) root cause investigations and maintain evidence of follow-up actions
• Support with any other Quality-related investigations and improvements as directed by the Quality Manager