The purpose of the Quality Assurance Officer-Team Leader is to provide support to the overall Company on QA aspects, and to assist and maintain regulatory compliance against ISO 13485 and Medical Device Directives, MDD 93/42/EEC, and will be based in Midrand. Key Job Functions: Sampling of product Quality Control Environmental Monitoring Inspection of samples Incoming goods inspection (AQL) Validation Calibration 1. Sampling of product Verification, inspection and release of product/consumable samples, analysis, record keeping and filing of batch documents. Inspecting of Autoclave envelopes and the analysis of the daily Bowie and Dick and Microbiological results from the sterilisers as per legislation and communicate issues to the Production Manager. Record any unsterile runs in the spreadsheet and communicate with the Maintenance Department. Follow the environmental Monitoring schedules for the sampling, preparing, incubating, analysing, recording and monitoring of microbial swabs of products and areas of production. Conduct microbiological/environmental testing as per schedule. Compile all records required per batch before a batch can be released. Filing, archiving of documentation. 2. Inspection Final batch inspections post sterilisation. Incubation of Biological Indicators post sterilisation. Ensure seal strength is completed for all batches before they can be released. 3. Microbiology Ensure all environmental monitoring are performed as per schedule. Identify areas of improvements in the cleanroom to avoid cross contamination. Ensure trend analysis for all environmental results is completed on a monthly basis. Management and oversight of junior staff performing Microbiological monitoring activities. 4. Incoming Goods Inspections (AQL) Incoming goods inspections according to the approved technical and responsible for the approval of final documentation of the AQL process. Insure a full AQL Sampling process is implemented for all materials received on site. Insure all SOPs related to AQL processes are up to date and adhered to. Ensure compliance for the overall AQL Process specification. Management and oversight of results generated by junior staff performing inspection of good activities. 5. Control of non-conforming products Coordinate the Quarantine process. Ensure Quarantine spreadsheet is always up to date. Ensure all quarantine products are segregated and placed in quarantine location. Follow-up on closing off of open quarantine forms. Sign-off Quarantine forms and ensure stock is released from Quarantine as required. 6. Auditing Conduct internal auditng as per annual schedule and compile reports. 7. Documentation Creating and/or signing off of SOP's, standard forms and any additional documentation relating to quality, improvement projects, and product and/or process validations. 8. Sampling of product, Bioburden testing and Report Writing Ensure retention samples of finished goods are maintained, and notify the QA Manager when testing is required or space becomes an issue. Prepare any samples that need to be sent for sterility and Bioburden testing. Co-ordinate the receiving of samples for testing from the warehouse on a regular basis. Inspection of incoming samples, release of consumables/goods on Granite/Evo. Reports on analysis of consumables and garment/drape materials. Receive sterilisation COCs and save them into the QMS. Write reports for all batches that are ready to be released on Granite/Evo. 9. Deviations Maintain the Quality Management System (QMS) by following up, initiating and trending of all Deviations. Initiate, populate and manage Deviation register and follow-up of open Deviation reports. Provide monthly updates to the QA Manager on the outstanding Deviations. Follow-up and ensure the closing off of Deviations. 10. Batch Control, Records and Release Creating pulling lists as per approved BOM. Creating labels as per approved BOM. Check all completed batch records, make sure all documentation is attached and release the batch as required. Management and oversight of results generated by junior staff performing batch release inspection activities. Ensure all quality control processes is adhered to during production. Ensure compliance to all quality processes during production. Coach Quality Controllers about best practices and following procedures during production. Identify any training needs for all Quality Controllers. Ensure effectiveness checks of all processes is completed. Ensure Quality Controllers do inspections of all completed batches before it can be released to warehouse, check for completeness of batch records as well. Review final batch documents are complete, all inspections is completed and is within specified criteria before batch is released. Management and oversight of results generated by junior staff performing batch release inspection activities. 11. Validation of products, processes and equipment Validation of Projects and report writing namely (but not limited to): o Validation of sterilisation equipment which includes IQ, OQ & PQ for both steam and EO sterilisation o Validation of packaging (steam and EO) with regards to re-use, seal strength, dye penetration and effect of aging o Validation of cleanroom particle counts o Cleaning validation o Temperature and Humidity logger verification 12. Calibration Lease with maintenance to ensure all equipment on site are calibrated as per approved calibration schedule. Notify QA Manager if equipment will not be calibrated in time. Ensure all quotes are requested in time from service providers to avoid delays on calibration dates. 13. Technical Specifications (AQL) Implement technical specifications for all raw materials on site. Ensure correct information is displayed in each technical specification. Review technical specifications on a regular basis to ensure compliance. 14. Training Ensure new QA personnel are trained in all processes. 15. Supervision Supervision of junior staff performing laboratory activities and Incoming goods release activities. Minimum Qualifications Matric/Grade 12 Basic Microbiology Minimum Experience 3-5 years of experience in the laboratory / medical device industry Total Quality Management System Course Knowledge of Granite, Evolution and Electronic QMS (Isometrix) systems Knowledge ISO 13485 Basic understanding of Microbiology Regulatory Procedures/Practices Knowledgeable about clean rooms Addressing root cause when investigating corrective actions Validation Incoming Goods Laboratory practices TQM Principles Skills Basic mathematical skills Apply Now

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