Quality Assurance Coordinator
18 ore fa
OverviewMain Purpose of Role: Maintenance of the NB 1639 medical device internal quality management system.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.ResponsibilitiesManaging of daily QA tasks: Updating 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.Management 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 documents.Qualifications & SkillsEssential :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 the main MS office tools (Word Excel Outlook)Fluent written and spoken English.A 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 9001.ExperienceEssential : Significant work experience in a position with QA responsibility.A nice to have : Experience working with medical devicesAuditing experience against recognised standards.QualificationsEssential : Bachelors 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 documents.How to ApplyPlease send your CV in EnglishAdditional InformationWhy SGS — Global and very stable company world leader in the TIC (Testing Inspection and Certification) industry.Flexible schedule and hybrid model.SGS university and Campus for continuous learning options.Multinational environment where you will work with colleagues from multiple continents.Benefits platform.Join Us: At 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 Work: YesEmployment Type: Full-timeKey SkillsQuality Assurance, FDA Regulations, Data Collection, Food Industry, ICH Q7, ISO 9001, Hospice Care, Food Processing, Quality Management, cGMP, QA / QC, HACCPExperienceyearsVacancy1#J-18808-Ljbffr
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Quality Assurance Coordinator
1 settimana fa
Rome, Italia Altro A tempo pienoOverviewMain Purpose of Role: Maintenance of the NB 1639 medical device internal quality management system. 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....
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