Quality Assurance Officer (1 year maternity cover)

ph3Quality Assurance Officer (1 year maternity cover) /h3 ulliFull-time /li /ul pWe 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. /p pAt 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. /p pbMain Purpose of Role: /b /p ul liMaintenance of the NB 1639 medical device internal quality management system. /li /ul pbManaging of daily QA tasks: /b /p ul liUpdating and maintenance of documents under the MDD, MDR and IVDR scheme, /li liManagement the IF database, /li liCollaboration on generic scheme documents, /li liPublishing of documents on the SGS website, /li liBizzmine (Quality Management System); user communication and maintenance. /li /ul pbThis role will report to the Quality Regulatory Manager, Business Assurance. /b /p pbIt 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. /b /p pbKey Accountabilities: /b /p ul liManagement of complaints, compliance queries and appeals, /li liManagement of continual improvement, /li liManagement of document control and records, /li liPerform quality assurance check on updated quality management system documents, /li liRelease of updated quality management system documents in Bizzmine, /li liBuild a good working relationship with the Global Medical Device Certification / Competency / /li liTechnical and Clinical Manager(s), and other Global Medical Device Team members, /li liUndertake personal professional development and ensure appropriate training records are /li liupdated, /li liProvide technical support to all parts of the business, /li liMaintain a full knowledge and understanding of SGS procedures, regulations, guidance /li lidocuments (e.g., MDCG) and external approval criteria, /li liSupport the development and maintenance of combined scheme documents. /li /ul pbSkills Knowledge /b /p ul liGood working knowledge of quality management systems including CAPA management, /li lidocument control and good documentation practices (GDP), /li liDetail oriented, /li liStrong organisational skills, /li liAbility to organise own workload considering priorities set by the global medical device quality /li limanager, /li liAbility to adapt quickly and demonstrate flexibility, /li liAbility to work in a team, /li liAbility to write clear procedures, /li liGood working knowledge of the main MS office tools (Word, Excel, Outlook), /li liFluent written and spoken English. /li /ul pbA nice to have: /b /p ul liDetailed understanding of global medical device regulations MDR and IVDR, and medical /li liKnowledge of accreditation standard ISO 17021-1:2015, ISO 13485, ISO 9001. /li /ul pbExperience /b /p ul liSignificant work experience in a position with QA responsibility. /li /ul pbA nice to have: /b /p ul liExperience working with medical devices, /li liAuditing experience against recognised standards. /li /ul pbQualifications /b /p ul liBachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nurse, or similar) /li /ul pbA nice to have: /b /p ul liMedical device training on MDD, MDR, IVDR or ISO 13485 /li /ul pbPerformance Indicators: /b /p ul liTurnaround time for compliance issues/complaints/ appeals, /li liEfficient running of QMS and release of quality management documents. /li /ul pbWhy SGS? /b /p ul liJoin a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry. /li liEnjoy a flexible schedule andwork model. /li liAccess SGS University and Campus for continuous learning options. /li liThrive in a multinational environment, collaborating with colleagues from multiple continents. /li liBenefit from our comprehensive benefits platform. /li /ul pbJoin Us: /bAt SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential. /p /p #J-18808-Ljbffr