Quality and Compliance Officer – Medical Devices - JOBS.ac.kr(잡스) - 대한민국 최대 석박사 채용정보, 잡스!

{"job":{"jobId":2449245,"fk_accountId":null,"fk_organizationId":494,"fk_adminAccountId":null,"title":"Quality and Compliance Officer – Medical Devices","description":"\n\nJob description\n\n\nThis is an exciting opportunity for an experienced quality professional to support the design, development and manufacturing of innovative medical devices for first-in-patient clinical investigations.  \n\n\n \n\n\nThe post holder will be based in the School of Biomedical Engineering &amp; Imaging Sciences, King's College London. Located within a hospital environment, our mission is to generate tangible clinical and commercial translation through our stimulating collaborations to achieve the unexpected, and advance research, innovation and teaching progress through our shared mission of engineering better health for patients worldwide. The Quality and Compliance Officer will support the operation of the new facility for the Manufacture of Active Implants and Surgical Instruments (MAISI) and work with research teams developing state-of-the-art medical technology, including surgical robotics, imaging software and AI, to follow the Medical Engineering Quality Management System (QMS) procedures. \n\n\n \n\n\nThe individual will join a growing Quality Team and work with clinicians, staff and students in a clinical academic setting to ensure medical devices meet regulatory, quality and safety standards.  You will be required to work on implementing and maintaining key processes in the quality system and will be joining the team as the manufacturing facility is constructed and undergoes validation in 2023. \n\n\n \n\n\nThe individual will report to the Manufacturing Quality Assurance Lead – Medical Devices, and work with all users of the QMS including production staff, research groups, and top management. The post holder will be required to ensure compliance and readiness of the quality system to ISO 13485 in preparation for certification. \n\n\n \n\n\nThis post will be offered on  a fixed-term contract for 2 years \n\n\nThis is a full-time post - 100% full time equivalent\n\n\n \n\n\nKey responsibilities\n\n\n•       Perform document control activities, including creating, distributing, modifying, storing and reviewing documents and records. Inform staff of the release of new documents and revisions.\n\n\n•       Manage and retain accurate records of any reported deviations and violations.\n\n\n•       Coordinate and manage completion of complaints, change control, non-conformance, corrective and preventive actions.\n\n\n•       Assist with management of training records as required.\n\n\n•       Schedule Management Review and Quality Meetings, ensuring outputs are recorded.\n\n\n•       Reviewing and approving validation plans/protocols and reports.\n\n\n•       Supporting the requestor, when required, in the processes associated with supplier planning for supplier approval. Conduct supplier evaluations.\n\n\n•       Support cleanroom team with review and approval of commissioning, IQ, OQ, PQ, validation and operating documentation.\n\n\n•       Perform QA product release and batch record review of sterile and non-sterile products.\n\n\n•       Assist in inspection, approval and testing of incoming materials and components.\n\n\n•       Review the monitoring and reporting of cleanroom environmental monitoring, product bioburden trends etc.\n\n\n•       Participate in internal and external audits\n\n\n•       Support the operation and implementation of an electronic QMS\n\n\n•       Support manufacturing QC testing program\n\n\n•       Initial review of documents and batch records\n\n\n•       Ensure compliance of quality system and collate quality system metrics\n\n\n•       Organise, deliver and participate in internal and external training sessions\n\n\n \n\n\nThe above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post. \n\n\n \n\n\nSkills, knowledge, and experience\n\n\nEssential criteria\n\n\n1.       Degree or equivalent experience in engineering discipline (biomedical, electronic, mechanical, materials), quality, or related subject.\n\n\n2.       Knowledge of quality system standards and regulation, e.g. ISO 13485, 21 CFR 820, AIMD, MDD and MDR.\n\n\n3.       Experience in writing and reviewing quality system documentation including standard operating procedures, templates, forms and records, to ensure compliance with requirements.\n\n\n4.       Knowledge / experience of good manufacturing practices and medical device or similar cleanroom manufacturing and operation.\n\n\n5.       Experience of developing and implementing appropriate measures and tests of quality.\n\n\n6.       Competence in use of QMS and IT tools, including MS Office, Sharepoint, MS Teams, Word, Excel and Outlook.\n\n\n7.       Experience in document control and use of document management system.\n\n\n8.       Attention to detail with excellent organisational, written, verbal communication skills and ability to troubleshoot.\n\n\n9.       Ability to work collaboratively with different teams to agreed deadlines.\n\n\n10.   To embrace the challenge of setting-up a new facility be flexible, open-minded and creative with innovative ideas and a can-do attitude to provide solutions to establish a compliant facility.\n\n\n \n\n\nDesirable criteria\n\n\n1.       Experience of monitoring and reporting of cleanroom environment, product bioburden trends, or endotoxin testing.\n\n\n2.       Participation in audits.\n\n\n3.       Experience of chairing meetings and taking formal minutes.\n\n\n4.       Experience of QC testing\n\n\n","pdfUrl1":null,"location":"London (Greater) (GB)","location1":"유럽","location2":null,"location3":null,"type":"4","applyUrl":"https://jobs.kcl.ac.uk/gb/en/job/053587/Quality-and-Compliance-Officer-Medical-Devices","fileUrl1":null,"fileUrl2":null,"fileUrl3":null,"fileUrl4":null,"fileUrl5":null,"fileUrl6":null,"fileUrl7":null,"workingHour":"Full Time","contractType":"Fixed Term","salary":"£40,386 to £47,414 per annum, including Londo","original_id":"UNI|307311","original_domain":"timeshighereducation.com","original_url":"https://www.timeshighereducation.com/unijobs/listing/307311","original_isPremium":null,"closeType":1,"closedAt":"2023-08-31T00:00:00.000Z","requireEducation":10,"managerTel":null,"managerFax":null,"managerEmail":null,"managerName":"KINGS COLLEGE LONDON","managerPhone":null,"managerAddress":"London (Greater) (GB)","log_hit":7,"log_like":0,"publishState":1,"organizationName":null,"organizationName_en":null,"organizationName_alt":null,"del_yn":"N","createdAt":"2022-09-01T17:36:20.000Z","updatedAt":"2022-09-01T17:36:20.000Z"},"organization":{"organizationId":494,"lv1Id":null,"lv2Id":null,"name":"King’s College London","name_en":"KINGS COLLEGE LONDON","name_alt":",King’s College London,KINGS COLLEGE LONDON,","introduction":"King’s is a leading university providing world-class teaching and cutting-edge research. We are ranked sixth in the UK for the quality and quantity of research activity (Research Excellence Framework 2014). King’s has played a major role in many of the advances that shape modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar. King’s continues to lead the way on research and pioneers new ideas to make the world a better place.&nbsp;King’s is London’s most central university, with five campuses linked through the heart of the capital, enabling us to build partnerships with key London institutions and form international conversations. We collaborate on research projects, share teaching resources and create internship opportunities to enhance our students’ experience. Current partners include the British Library, British Museum, National Gallery, Shakespeare’s Globe, Southbank Centre, Tate Modern, and more. Our central location and varied partnerships allow students to get connected in one of the world’s most dynamic cities.King’s is not only an enriching experience from an academic perspective – we have a diverse and active student community, with almost 30,000 students from some 150 countries worldwide.","logoImg":"","logoImgSquare":"https://s3.ap-northeast-2.amazonaws.com/jobs.ac.kr/dev/images/fdoip_897356079989.png","homepageUrl":"https://www.kcl.ac.uk/study","infoUrl":"https://www.timeshighereducation.com/world-university-rankings/kings-college-london","country":"GB","state":"London","location":"유럽","address":"Strand, London, WC2R 2LS, United Kingdom","phoneNumber":"+44 20 7836 5454","faxNumber":"","type":1,"univType1":"대학","univType2":"대학교","univType3":"","univType4":"본교","establishedAt":"1829-01-05T00:00:00.000Z","count_majors":null,"count_students":null,"meta_competitiveness":"","publishState":1,"updatedAt":"2021-03-23T10:36:30.000Z","createdAt":"2020-03-04T20:13:07.000Z","default_1_bannerImage":null,"default_1_bannerImageMobile":null,"default_2_bannerImage":null,"default_2_bannerImageMobile":null,"default_3_bannerImage":"https://s3.ap-northeast-2.amazonaws.com/jobs.ac.kr/production/images/1664358856424/special_King’s College London.jpg","default_3_bannerImageMobile":null}}