Description 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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options. CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com. Responsibilities Responsible for Quality Systems at RI Cooper Surgical (Falmouth). This role focuses on managing and maintaining accurate Quality Management System (QMS) records and ensuring compliance within regulatory frameworks, company policies, and quality standards relevant to the site’s operations. The Quality Systems Coordinator will also support the Quality Manager in maintaining site-wide adherence to ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements. This role is responsible for managing, operating, and maintaining the Quality Management System (QMS) while leading the effective resolution of quality activities, including Non-Conformances (NCs) and Corrective and Preventive Actions (CAPAs). It requires close collaboration with departments at the Falmouth site and global stakeholders across Cooper Surgical (CSI). A strong understanding of both local RI procedures and CSI global processes is essential to align site-specific activities with global standards and ensure ongoing compliance with QMS requirements. Responsibilities: Support in all activities for creation, implementation, and maintenance of Quality Management Systems (QMS) to meet the requirements of ISO 13485, FDA 21 CFR part 820, MDSAP, and relevant Medical Device Directives and Regulations Assist in the Corrective and preventive action (CAPA) process, including initiation, investigation, root cause analysis, and corrective/preventive action implementation. Monitor CAPA timelines and ensure actions are completed as scheduled. Track and trend CAPA effectiveness, generating reports for management review. Monitor NCMRs and perform trend analysis to identify recurring issues. Maintain accurate and auditable records of non-conformance investigations. Identify opportunities for process improvements within the QMS and operations. Identify metrics to track improvement activities and ensure alignment with Quality objectives. Support in the planning, preparation, follow-up, and execution of internal audits Support in the preparation for external audits. Assist with meetings such as Management Review and act as a deputy and minute taker to the Quality Manager in this area Ensure all quality documentation is up-to-date, accessible, and compliant with relevant industry standards ISO 13485, FDA 21 CFR Part 820, EU MDR) and local regulatory requirements. Contribute proactively within a small team and be prepared to assist as needed to meet business demands. Support with any other Quality related investigations and improvements as directed by the Quality Manager Escalate immediately to the Quality Manager in any case where potential risks are identified. Prepare reports and presentations for management reviews and audits related to CAPA, NCMRs, and Continuous Improvement. Track and monitor key performance indicators (KPIs) to ensure the effectiveness of quality processes. Qualifications Qualifications: Experienced in monitoring progress of actions and running small projects Hands-on experience in auditing and being audited Experience with document control and GMP Preferably background in Quality Assurance and Quality Control within the Medical Devices Industry Minimum 2 years’ work experience in Quality Assurance Experience and solid knowledge of ISO13485 quality systems Preferably knowledge of EU Medical Device Regulations Preferably Internal/External audit experience Education: You need to be highly literate in the English language to the level of a native speaker. Completed high school or equal. You need to be qualified to audit internally You need to be Knowledgeable and trained in ISO 13485 and FDA 21 CFR, part 820.