Job DescriptionContinui a leggere per comprendere appieno cosa richiede questo lavoro in termini di competenze ed esperienza. Se il suo profilo è in linea, invii la sua candidatura.Your roleWe are looking for a QA Specialist who will join the Quality & Regulatory Affairs team and support the maintenance and continuous improvement of the company's Quality Management System, ensuring compliance with applicable medical device requirements and contributing to Quality Assurance activities throughout the entire product lifecycle.The role requires the ability to work in a dynamic, cross-functional environment, collaborating closely with Production, R&D, Regulatory Affairs, and external suppliers.Main ResponsibilitiesSupport the maintenance and continuous improvement of the Quality Management System in accordance with ISO 13485, MDSAP and applicable regulatory requirementsDraft, update, and review procedures, work instructions, forms, and QMS records.Support the management of changes affecting the Quality Management System and company processes.Support internal and third-party auditsSupport the management of non-conformities, CAPAs and quality-related complaints, including root cause analysis, corrective actions and trend identification.Support supplier quality activities, including supplier qualification and monitoring, audits,



non-conformity management and corrective actionsSupport Quality Assurance activities related to manufacturing and servicing, including the management of quality issues and compliance of related processes and records.Main RequirementsDegree in a scientific, engineering, or related field.Preferably 1–3 years of experience in Quality Assurance within the medical device industryKnowledge of ISO 13485.Basic knowledge of Regulation (EU) 2017/745 (MDR).Familiarity with processes such as non-conformities, CAPA, Change Control, supplier management, audits, and document control.Good written and spoken English.Good IT skills and ability to manage technical and quality documentation.The Following Will Be Considered An Advantageknowledge of MDSAPexperience with electromedical deviceexperience with third party, internal and/or supplier audits.Salary PackageAnnual Gross Salary: 30.000 Eur – 35 .000 EurOur Diversity, Equity and Inclusion commitmentWe are committed to creating an inclusive environment for all employees. xysqume We celebrate diversity and provide equal opportunities to all, regardless of race, gender, ethnicity, religion, disability, sexual orientation, or any other characteristic that makes us unique.#J-18808-Ljbffr

📌 Qa Specialist (Reggio Emilia)
🏢 EssilorLuxottica
📍 Reggio Emilia