Sub-Saharan AfricaGreat that you're thinking about a career with BSI!Sub-Saharan Africa

Sub-Saharan AfricaRole Title: Global Quality & Accreditation: Technical and Regulatory ReviewerSub-Saharan Africa

Sub-Saharan AfricaReporting: Global Quality & Accreditation: Technical ManagerSub-Saharan Africa

Sub-Saharan AfricaLocation: UK/EU/APAC - HomebasedSub-Saharan Africa

Sub-Saharan AfricaThe role is to provide medical device quality management system ownership to medical device and QMS audit teams globally.Sub-Saharan Africa

Sub-Saharan AfricaThe Role Comprises Of Three Main ElementsSub-Saharan Africa

• Sub-Saharan AfricaDeveloping and maintaining technical expertise in key areas relating to certificate decision making, competence verification and competence monitoring;Sub-Saharan Africa
• Sub-Saharan AfricaSupporting in ad hoc improvement projects;Sub-Saharan Africa
• Sub-Saharan AfricaTechnical support of the ISO 13485 certification based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as MDSAP and CE.Sub-Saharan Africa
  
  
  

Sub-Saharan AfricaResponsibilities & AccountabilitiesSub-Saharan Africa

• Sub-Saharan AfricaSupport the roll out of policy decisions and processes for medical device QMS audits globally;Sub-Saharan Africa
• Sub-Saharan AfricaProvide support of the ISO 13485 certification and CE schemes, for example investigating customer appeals, report reviewing and supporting activities during regulator audits;Sub-Saharan Africa
• Sub-Saharan AfricaDeliver certification decisions for ISO 13485 certifications as eligible, with a goal to being qualified across all non-CE ISO13485 schemes, where resource allows;Sub-Saharan Africa
• Sub-Saharan AfricaParticipating in smaller improvement projects ensuring appropriate adherence to procedures;Sub-Saharan Africa
• Sub-Saharan AfricaSupport in hosting regulator or accrediting body auditsSub-Saharan Africa
• Sub-Saharan AfricaProvide advice and support to QMS auditors globally, technical specialists, scheme managers, sales, marketing and other BSI colleagues on BSI QMS requirements for medical devices;Sub-Saharan Africa
• Sub-Saharan AfricaCompetence verifier activities to support the auditor qualification process, if appropriate.Sub-Saharan Africa
  
  
  

Sub-Saharan AfricaSuitable Candidates Should Demonstrate The FollowingSub-Saharan Africa

• Sub-Saharan AfricaA good understanding of QMS requirements as applied to medical devices including applicable regulations and standards (ISO 13485 and MDD, AIMD and/or IVDD, MDR/IVDR and MDSAP requirements in particular).Sub-Saharan Africa
• Sub-Saharan AfricaA good understanding of product and QMS certification concepts and principlesSub-Saharan Africa
• Sub-Saharan AfricaA comprehensive understanding of quality systems, philosophies and principles
• Sub-Saharan AfricaAn awareness of certification, accreditation and notified body rolesSub-Saharan Africa
• Sub-Saharan AfricaExperience of co-ordinating or conducting audits of medical device manufacturers to ISO13485 (e.g. supplier or internal audits)Sub-Saharan Africa
• Sub-Saharan AfricaMinimum of two years of hands-on medical device manufacturing experience and two years quality management experience for medical devices.Sub-Saharan Africa
  
  
  

Sub-Saharan AfricaOur Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.Sub-Saharan Africa

Sub-Saharan AfricaBSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.Sub-Saharan AfricaSub-Saharan Africa