Quality Assurance Officer
6 giorni fa
Main Purpose of Role :Maintenance of the NB 1639 medical device internal quality management system.Managing of daily QA tasksUpdating and maintenance of documents under the MDD MDR and IVDR schemeManagement the IF databaseCollaboration on generic scheme documentsPublishing of documents on the SGS websiteBizzmine (Quality Management System); user communication and maintenance.This 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 areupdatedProvide technical support to all parts of the businessMaintain a full knowledge and understanding of SGS procedures regulations guidancedocuments (e.g. MDCG) and external approval criteriaSupport the development and maintenance of combined scheme documents.Qualifications – Skills & KnowledgeEssentialGood working knowledge of quality management systems including CAPA managementdocument control and good documentation practices (GDP)Detail orientedStrong organisational skillsAbility to organise own workload considering priorities set by the global medical device qualitymanagerAbility to adapt quickly and demonstrate flexibilityAbility to work in a teamAbility to write clear proceduresGood working knowledge of the main MS office tools (Word Excel Outlook)Fluent written and spoken English.A nice to haveDetailed understanding of global medical device regulations MDR and IVDR and medicaldevice directive MDDKnowledge of accreditation standard ISO 17021-1 : 2015 ISO 13485 ISO 9001.ExperienceEssentialSignificant work experience in a position with QA responsibility.A nice to haveExperience working with medical devicesAuditing experience against recognised standards.Educational QualificationsEssentialBachelors degree (or higher) in Biomedical Sciences or similar field (e.g. pharmacy bioengineering nurse ...)A nice to haveMedical 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 documents.Please send your CV in EnglishAdditional InformationWhy SGSGlobal and very stable company world leader in the TIC (Testing Inspection and Certification) industry.Flexible schedule and hybrid model.SGS university and Campus for continuos learning options.Multinational environment where you will work with colleagues from multiple continents.Benefits platform.Join 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.Remote WorkYesEmployment TypeFull-time#J-18808-Ljbffr
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