Quality Operations Specialist

Affluent Medical is a French MedTech company specialized in the international development and industrialization of innovative, clinical-stage medical prostheses to treat urinary incontinence and mitral heart failure. The product portfolio currently includes 3 innovative prostheses: Artus: The first artificial sphincter activated by a remote control, for the treatment of moderate and severe urinary incontinence in men and women. KaliosTM: the only prosthesis for the repair of the cardiac mitral valve, which allows multiple post-operative readjustments of the mitral valve by transcatheter route without general anesthesia. Epygon: the only physiological cardiac bio prosthesis that mimics the native mitral valve and blood flow and can be implanted without “open heart” surgery. Their markets are global in scope and are expected to be worth more than €10 billion by 2027. As part of its development, we are looking for a: Quality Operations Specialist This job is based in Collareto Italy. Reporting to the Director of Quality for Affluent Medical the Quality Engineering Specialist is responsible for the quality oversight of design control and production activities for medical devices manufactured by Epygon Italy. This role involves close collaboration with various teams throughout the device life cycle. Tasks: Lead quality review and approval of all technical documentation for design and development, including planning, protocols, reports, risk assessments, testing, and more. Ensure compliance with company procedures and regulatory requirements. Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization. Support the timely handling of investigations, impact assessments, deviations, CAPAs, and technical matters related to design changes, verification, validation, and supply chain operations. Play an active role in the release of device components and finished devices according to critical quality characteristics. Lead or support sustainable, continuous improvement to the Quality Management System and best practices for device life cycle processes by identifying areas for improvement and engaging in remediation. Manage QA interface with medical device or device component suppliers and testing partners by providing technical and quality support during the development, testing and manufacture at supplier sites. Prepare and manage quality agreements. Support internal and external audits and inspections as a device quality expert. Develop and impulse continuous improvement. Profile: You have a minimum of a BS in Biomedical/Quality Engineering or related technical or scientific discipline. With 3-5 years of working experience within a medical device, biotech, or pharmaceutical company. Your experience includes experience of device processes and documentation (including non-conformities, CAPA, change control processes). You are well-versed in device regulations, including 2017/745, ISO 13485, and ISO 14971, and having knowledge of 21 CFR 820. In addition, your skills extend to supplier management and relations, including the generation and maintenance of quality agreements. Demonstrate effective cross-functional and cross-cultural skills. You have strong organizational, prioritization, and execution skills, coupled with your attention to detail. And you also have leadership skills and excellent interpersonal, collaboration, and communication abilities. Moreover, your fluency in Italian and professional proficiency in English. J-18808-Ljbffr