Quality Assurance Coordinator

About CooperSurgical CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. Scope: The Quality Coordinator role supports the Quality Department at Research Instruments, Falmouth, UK. The Quality Coordinator supports the Quality Manager in maintaining overall site compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements, by taking responsibility for the maintenance of Quality Management System documentation and records, in particular employee training records and providing data for quality metrics monitoring. Job Summary: The Quality Coordinator supports quality systems, regulatory compliance, and continuous improvement within Research Instruments. Key responsibilities include managing quality documentation, coordinating employee training and maintenance of accurate training records, ensuring adherence to regulations and standards, gathering quality data for KPI monitoring and monthly trending, and collaborating with various departments to resolve quality issues and improve processes.