Manufacturing Quality Assurance Officer/Lead – Medical Devices - JOBS.ac.kr(잡스)

{"job":{"jobId":2498147,"fk_accountId":null,"fk_organizationId":494,"fk_adminAccountId":null,"title":"Manufacturing Quality Assurance Officer/Lead – Medical Devices","description":"\n\nJob description\n\n\nThis is an exciting opportunity for a Quality Assurance (QA) professional to join a team establishing a new cleanroom facility for the production of medical devices for first use in human. The facility MAISI (<a data-mz=\"\" href=\"https://www.kcl.ac.uk/bmeis/our-centres/maisi\" rel=\"no-follow\">https://www.kcl.ac.uk/bmeis/our-centres/maisi</a>) will support the production of active implants and multi-modal surgical instruments.\n\n\nThe individual will join an active Quality and Regulation team (5 people plus the post holder). Their role will be to provide QA support to the cleanroom production team, including continuing the work implementing and maintaining a quality system for ISO 13485 certification. The role may include line management of a QA officer already within our team, depending on the post holder’s previous experience.\n\n\nThe post holder will work alongside the three engineers operating the facility, and be responsible for interpreting and advising on good manufacturing practices for medical devices and ensuring that production and testing are compliant with relevant regulations.\n\n\nThis post will be offered on a fixed-term contract until 05 February 2026,  with a view to extend when further funding becomes available.\n\n\nThis is a full-time post - 100% full time equivalent.\n\n\n \n\n\nKey responsibilities\n\n\n<ul>\n<li>To work in collaboration with other members of the production and quality teams to develop fit-for-purpose processes.  </li>\n<li>Write, review, approve, issue and archive quality system documents.  </li>\n<li>Ensure compliance to relevant standards and regulations (external and internal) as appropriate e.g. ISO13485, ISO14644.</li>\n<li>Ensure devices are manufactured to acceptable safety and quality standards. </li>\n<li>Support cleanroom team with review and approval of commissioning, IQ, OQ, PQ, validation and operating documentation. </li>\n<li>QA product release and batch record review of sterile and non-sterile products. </li>\n<li>Assist in inspection, approval and testing of incoming materials and components.  </li>\n<li>Coordinate and manage completion of non-conformance, corrective and preventive actions. Lead root cause analysis activities. </li>\n<li>Review the monitoring and reporting of cleanroom environmental monitoring, product bioburden trends etc. </li>\n<li>Maintenance of training system and documentation. </li>\n<li>Assign, monitor and report quality assurance metrics. </li>\n<li>Support change control through review and approval of documentation, ensuring adequacy of verification or validation to support the change, good documentation practices and compliance to procedures. </li>\n<li>Liaise with staff, customers, suppliers and external bodies to exchange information on quality system processes. Deal with directed queries. </li>\n<li>Conduct supplier evaluations and ensure supplier agreements are in place where required. </li>\n<li>Carry out internal audits and participate in Notified or Approved Body audits.  </li>\n<li>Develop, organise and participate in internal and external training sessions. </li>\n<li>Member of Management Team to ensure continued compliance of facility. </li>\n<li>Interpret trends or patterns in data for management review. </li>\n<li>Deputise for the Medical Engineering QMS Director as required.  </li>\n</ul>\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 (Grade 6 - Officer)\n\n\n<ol>\n<li>Degree or equivalent experience in relevant area, such as an engineering discipline (biomedical, electronic, mechanical, materials), microbiology or pharmacy. </li>\n<li>Knowledge of good manufacturing practices for medical device or similar cleanroom manufacturing and operation. </li>\n<li>Knowledge of quality system standards and regulation e.g. ISO13485, 21 CFR 820, and MDR. </li>\n<li>Knowledge of risk management e.g. ISO14971, ICH Q9 </li>\n<li>Experience of developing and implementing appropriate measures and tests of quality. </li>\n<li>Competence in use of QMS and IT tools, including MS Office, Sharepoint, MS Teams, Word, Excel and Outlook. </li>\n<li>Experience in writing and reviewing quality system documentation including standard operating procedures, template, forms and records, to ensure compliance with quality system requirements. </li>\n<li>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. </li>\n</ol>\n\n\nDesirable criteria (Grade 6 - Officer)\n\n\n<ol>\n<li>Experience in document control and use of document management system. </li>\n<li>Experience of monitoring and reporting of cleanroom environment, product bioburden trends, or endotoxin testing. </li>\n<li>Experience in development, testing or manufacturing of medical devices or similar regulated products. </li>\n<li>Knowledge of root cause analysis techniques. </li>\n</ol>\n\n\nEssential criteria (Grade 7 - Lead)\n\n\n<ol>\n<li>Degree or equivalent experience in relevant area, such as an engineering discipline (biomedical, electronic, mechanical, materials), microbiology or pharmacy. </li>\n<li>Knowledge and experience of good manufacturing practices and medical device or similar cleanroom manufacturing and operation. </li>\n<li>Knowledge and training in medical device quality systems and regulatory processes e.g. ISO13485, 21 CFR 820, and MDR. </li>\n<li>Knowledge of risk management e.g. ISO14971, ICH Q9, and experience of root cause analysis techniques and control of non-conformances. </li>\n<li>Experience of developing, implementing and reporting appropriate measures and tests of quality. </li>\n<li>Competence in use of QMS and IT tools, including MS Office, Sharepoint, MS Teams, Word, Excel and Outlook. </li>\n<li>Experience in writing and reviewing quality system documentation including standard operating procedures, template, forms and records, to ensure compliance with quality system requirements. </li>\n<li>Experience in manufacturing or testing of medical devices or similar regulated products, including experience of incoming inspection practices to verify that the components and materials meet the specification. </li>\n<li>Experience of monitoring and reporting of cleanroom environment, product bioburden trends, or endotoxin testing. </li>\n<li>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. </li>\n</ol>\n\n\nDesirable criteria (Grade 7 - Lead)\n\n\n<ol>\n<li>Trained Auditor, with experience of supplier audits. </li>\n<li>Experience in equipment qualification and validation </li>\n<li>Experience in terminal sterilization process method development and validation</li>\n</ol>\n\n\n \n\n\nFurther information\n\n\nAbout MAISI\n\n\nThe facility for the Manufacturing of Advanced Implants and Surgical Instruments (MAISI) will be located in the School of Biomedical Engineering and Imaging Sciences. MAISI will be a dedicated sub-contract manufacturing facility, fully staffed and equipped to build advanced active implantable medical devices and surgical instruments for first-in-human studies. The facility shall enable funded research to achieve its full impact by supplying prototypes for clinical evaluation, accelerating the translation pathway for the future benefit of patients.  \n\n\n<a data-mz=\"\" href=\"https://www.kcl.ac.uk/bmeis/our-centres/maisi\" rel=\"no-follow\">https://www.kcl.ac.uk/bmeis/our-centres/maisi</a>. \n\n\nAbout the School of Biomedical Engineering and Imaging Sciences - <a data-mz=\"\" href=\"https://www.kcl.ac.uk/bmeis\" rel=\"no-follow\">https://www.kcl.ac.uk/bmeis</a>.\n\n\nThis post is subject to Occupational Health clearance\n\n\n","pdfUrl1":null,"location":"London (Central), London (Greater)","location1":"유럽","location2":null,"location3":null,"type":"4","applyUrl":"https://www.kcl.ac.uk/jobs/077647-manufacturing-quality-assurance-officerlead-medical-devices","fileUrl1":null,"fileUrl2":null,"fileUrl3":null,"fileUrl4":null,"fileUrl5":null,"fileUrl6":null,"fileUrl7":null,"workingHour":"Full Time","contractType":"Fixed Term","salary":"£42,405 - £60,221 per annum, including London","original_id":"UNI|356512","original_domain":"timeshighereducation.com","original_url":"https://www.timeshighereducation.com/unijobs/listing/356512","original_isPremium":null,"closeType":1,"closedAt":"2023-11-26T00:00:00.000Z","requireEducation":10,"managerTel":null,"managerFax":null,"managerEmail":null,"managerName":"KINGS COLLEGE LONDON","managerPhone":null,"managerAddress":"London (Central), London (Greater)","log_hit":0,"log_like":0,"publishState":1,"organizationName":null,"organizationName_en":null,"organizationName_alt":null,"del_yn":"N","createdAt":"2023-10-30T19:02:02.000Z","updatedAt":"2023-10-30T19:02:02.000Z"},"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/1699581072101/킹스칼리지 스페셜 공고.png","default_3_bannerImageMobile":"https://s3.ap-northeast-2.amazonaws.com/jobs.ac.kr/production/images/1699581076461/킹스칼리지 스페셜 공고.png"}}