Company OverviewWe are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.Main Purpose of RoleMaintenance of the NB 1639 medical device internal quality management system.Managing daily QA tasksUpdating and maintenance of documents under the MDD, MDR and IVDR schemeManagement of the IF databaseCollaboration on generic scheme documentsPublishing of documents on the SGS websiteBizzmine (Quality Management System); user communication and maintenanceThis role will report to the Quality & Regulatory Manager, Business Assurance. It is remote based, and we are open to candidates located everywhere across Europe. But they must hold a valid work permit for their country of residency.Key AccountabilitiesManagement of complaints, compliance queries and appealsManagement of continual improvementManagement of document control and recordsPerform quality assurance check on updated quality management system documentsRelease of updated quality management system documents in BizzmineBuild a good working relationship with the Global Medical Device Certification / Competency / Technical and Clinical Manager(s), and other Global Medical Device Team membersUndertake personal professional development and ensure appropriate training records are updatedProvide technical support to all parts of the businessMaintain a full knowledge and understanding of SGS procedures, regulations, guidance documents (e.g., MDCG) and external approval criteriaSupport the development and maintenance of combined scheme documentsQualificationsSkills & KnowledgeEssential: Good working knowledge of quality management systems including CAPA management, document control and good documentation practices (GDP)Detail orientedStrong organisational skillsAbility to organise own workload considering priorities set by the global medical device quality managerAbility to adapt quickly and demonstrate flexibilityAbility to work in a teamAbility to write clear proceduresGood working knowledge of MS Office tools (Word, Excel, Outlook)Fluent written and spoken EnglishA Nice To Have: Detailed understanding of global medical device regulations MDR and IVDR, and medical device directive MDDKnowledge of accreditation standard ISO 17021-1:2015, ISO 13485, ISO 9001ExperienceEssential: Significant work experience in a position with QA responsibilityA Nice To Have: Experience working with medical devicesA Nice To Have: Auditing experience against recognised standardsEssential: Bachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nurse, ...)A Nice To Have: Medical device training on MDD, MDR, IVDR or ISO 13485Medical device auditorPerformance IndicatorsTurnaround time for compliance issues/complaints/appealsEfficient running of QMS and release of quality management documentsPlease send your CV in EnglishAdditional InformationWhy SGS?Global and very stable company, world leader in the TIC (Testing, Inspection and Certification) industryFlexible schedule and hybrid modelSGS university and Campus for continuous learning optionsMultinational environment where you will work with colleagues from multiple continentsBenefits platformJoin UsAt SGS we believe in innovation, collaboration, and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.Seniority levelEntry levelEmployment typeFull-timeJob functionQuality AssuranceIndustriesRetail Office Equipment, Consumer Services, and Oil and GasReferrals increase your chances of interviewing at SGS by 2xGet notified about new Quality Assurance Coordinator jobs in Milan, Lombardy, Italy.
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