AREAS OF RESPONSIBILITY CHANGE CONTROL MANAGEMENT Managing the Group Change Management programs and databases in alignment with ISO 13485 requirements and ensuring deadlines are not missed Schedule change meetings and ensure change initiation documents are available Maintain Change Control Index and follow up on action completion Collate change control action evidence and once all evidence available prepare change pack for implementation and approval Trend KPI data and provide report timeously for Management Review RECALLS, FIELD SAFETY ACTIONS AND ADVERSE EVENTS Maintain Index for recalls, field safety actions and adverse events Prepare draft notification reports for recalls, field safety actions and adverse events Follow up on the status of recalls, field safety notifications and adverse events till closure report is prepared Reconcile customer acknowledgments and follow up with respective personnel to ensure recalls are closed timeously Prepare and provide reports and ensure SAHPRA timelines for reporting is adhered to Trend KPI data and provide report timeously for Management Review ASSISTANCE WITH SAHPRA, NRCS, RAD CON, ICASA APPLICATIONS Support in processes where actions are assigned Review Change control index per legal entity Prepare SAHPRA Application packs for QA RA Manager Review and Submission Maintain index for submissions Trend KPI data and provide report timeously for Management Review ASSISTANCE WITH EXPORT REGULATIONS AND ASSOCIATED PRODUCT REGISTERATIONS Support with investigation of Export requirements Support with product registrations associated with Export Markets Sub-distributor evaluation and support on approval process Trend KPI data and provide report timeously for Management Review Maintain index for submissions and country requirements MEDICAL DEVICE FILE Managing the Group Medical Device File programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed for provision of documents Follow up with allocated department Product Managers and Specialists for Product Dashboards and product lists Trend KPI data and provide report timeously for Management Review KPI DATA COLLECTION AND ANALYTICS Follow up with all sites and departments on monthly KPI data metrics Ensure data is provided as per approved KPI Metrics DOCUMENT CONTROL (External) Managing the Group Document Control programs and databases in alignment with ISO 13485 and Regulatory requirements and ensure deadlines are not missed Manage document email address and Shared-Point Maintain Document Index for internal documents and External documents eQMS Document Controller Function review and promote documents for approval after review Issue approved documents for training and follow up to completion as per training matrix create implementation pack for document to be rendered effective Effective documents to be distributed within the organisation as digital and hard copies Retrieval of superseded documents and archiving of digital records For External documents, ensure review performed and associated review documented, raise associated change controls where applicable Maintain Document Index for External and external documents Control the issue of external documents Retrieval of superseded documents and archiving of digital records Trend KPI data and provide report timeously for Management Review POST MARKET SURVEILLANCE Co-ordination of Post Market Surveillance Program for the Group Generate and maintain Schedule and follow up with Product Managers until completion of reports Scan and save reports on respective platforms Trend KPI data and provide report timeously for Management Review CUSTOMER COMPLAINT AND ADVERSE EVENT Managing the Group Customer Complaint and Adverse Event programs and databases in alignment with ISO 13485 and Regulatory requirements and ensure deadlines are not missed Ensure that complaint timelines are met Ensure Submissions for Adverse events are met Do follow-up as needed Trend KPI data and provide report timeously for Management Review SUPPLIER QUALITY Managing the Group and individual site Supplier Quality programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed for monitoring and evaluations Perform assigned Supplier Audits Review and evaluation of the Approved Supplier List and suppliers as well as raising and communicating supplier non-conformances (Supplier Quality Liaison) Initiate Change Controls for supplier change notifications received and follow up on actions ensuring completion by the timelines Trend KPI data and provide report timeously for Management Review TRAINING MANAGEMENT PROGRAM Managing the Group Training programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed Generate and maintain Training Matrix for Group and all Sites Generate and Maintain Training Curriculums on eQMS in alignment with Training Matrix and document control program Follow up on training completion and associated records Manage training email address and Training Shared-Point; Trend KPI data and provide report timeously for Management Review CALIBRATION MANAGEMENT (Back-up) Managing the Group Calibration programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed for Calibration Maintain and update Calibration Index and update Shared-Point with calibration certificates for the group Trend KPI data and provide report timeously for Management Review NON-CONFORMING PRODUCT Maintain Index for Non-conforming products Review and retain disposition files Trend KPI data and provide report timeously for Management Review GENERAL Support with External Audits as per allocated actions Document Control: Reviewing and updating of Standard Operating Procedures and Quality Documents General administrative duties including archiving, filing, issue of Quality Documents Training: Ensure assigned training is completed timeously Provide training on areas under responsibility Continuous Improvement Individual Quality Improvement Projects are assigned on an annual basis are completed in a timeous manner Identify improvement areas in processes under responsibility Recalls And Adverse Events Support in processes where actions are assigned Follow up on open recalls and Adverse Events and ensure on time closure RAD CON, NRCS, ICASA License Applications Support in processes where actions are assigned. Assistance with SAHPRA Applications Support in processes where actions are assigned Qualifications Matric (Grade 12) is a minimum requirement Diploma, N-Dip or B-tech Degree: Science/ Medical / Biological/ Technical; (Preferred) Experience required 5 Years working experience in the Medical, Healthcare, Laboratory Industry (Preferred) Advanced Computer Skills (MS Office Word, Excel, PowerPoint, Teams). Experience with data collection and trending Experience with Quality Management Systems ISO 13485 or ISO 9001 or any other ISO standard (Preferred) Experience with Regulatory Affairs and understanding of regulations (Preferred)

Click Go Apply to apply online!

---

More related positions

---