QA Specialist

27 ott - Bologna
EssilorLuxottica

h3Your role /h3 pWe 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. /p h3Main Responsibilities /h3 ul liSupport the maintenance and continuous improvement of the Quality Management System in accordance with ISO 13485, MDSAP and applicable regulatory requirements /li liDraft, update, and review procedures, work instructions, forms, and QMS records. /li liSupport the management of changes affecting the Quality Management System and company processes. /li liSupport internal and third-party audits /li liSupport the management of non-conformities, CAPAs and quality-related complaints, including root cause analysis, corrective actions and trend identification. /li liSupport supplier quality activities, including supplier qualification and monitoring, audits, non-conformity management and corrective actions /li liSupport Quality Assurance activities related to manufacturing and servicing, including the management of quality issues and compliance of related processes and records. /li /ul h3Main Requirements /h3 ul liDegree in a scientific, engineering, or related field.



/li liPreferably 1–3 years of experience in Quality Assurance within the medical device industry /li liKnowledge of ISO 13485. /li liBasic knowledge of Regulation (EU) 2017/745 (MDR). /li liFamiliarity with processes such as non-conformities, CAPA, Change Control, supplier management, audits, and document control. /li liGood written and spoken English. /li liGood IT skills and ability to manage technical and quality documentation. /li /ul h3The Following Will Be Considered An Advantage /h3 ul liknowledge of MDSAP /li liexperience with electromedical device /li liexperience with third party, internal and/or supplier audits. /li /ul h3Salary Package /h3 ul liAnnual Gross Salary: 30.000 Eur – 35 .000 Eur /li /ul h3Recruiting process /h3 pOur recruitment process may vary; If you are selected, you will be contacted by our recruiters to guide you through the specific steps for your application. /p h3Our Diversity, Equity and Inclusion commitment /h3 pWe are committed to creating an inclusive environment for all employees. 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. /p #J-18808-Ljbffr

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