Quality Systems Specialist

About the role

The Quality Systems Specialist is responsible for the development, structure, maintenance, and improvements of the Quality Management System. Tasks: Tasks: · Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels. · Work collaboratively and support process owners in reviewing, structuring, and documenting their functional new or improved processes. Structure and integrate multi-referential in the same management system such as IT management system Business Continuity Management system, EHS, finance. · Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR, MDSAP and other applicable regulations. · Actively monitor effectiveness of the quality management system and propose and execute improvement projects. · Lead complex quality initiatives (e.g. CAPA, process improvements, new processes, gap analyses, system integrations), make recommendations, develop and execute plans. · Plan and conduct internal audits by participating and leading internal audits, follow up on the findings with auditee through effective closure, and present the data for trending. · Support electronic QMS transition and take ownership of the software tools including QMS documentation and change control. · Support Operational Quality with the handling of non-conformities, tool activities approvals, finish product release. Requirements Required abilities: • Degree in Engineering, Scientific • 5+ years of quality-related system experience in a medical device company developing medical devices • Excellent technical writing, proofing, and language (grammar and spelling) skills with strict attention to details • Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR) • Certified lead auditor for ISO 13485 • Knowledge in certification 27001 is a plus • Excellent communication skills and interpersonal relationship skills • Advanced problem-solving, organizational, analytical and critical thinking skills • Electronic QMS experience is preferred • Fluency in English is a must Benefits What we offer: • A dynamic, innovative environment with cutting-edge medical technology that is shaping the future of robotic surgery. • Fast-growing Company where innovation meets agility. • Structured onboarding program and training, ensuring a confident start. • High degree of autonomy and flexibility.