Matric is essential
Diploma, N-Dip or B-tech Degree: Science/ Medical / Biological/ Technical (Preferred)
2 Years working experience in the Medical, Healthcare, Laboratory Industry (Preferred)
Advanced Computer Skills (MS Office Word, Excel, Powerpoint, Teams)
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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)
Training Management Program for Group
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 and retaining training records on respective platforms
Trend KPI data and provide report timeously for Management Review
Hold meetings as required to assist divisions and departments with planning training
Document Control
Managing the Group Document Control programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed
Manage document email address and Shared-Point
Maintain Document Index for internal 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Retrieval of superseded documents and archiving of digital records
Trend KPI data and provide report timeously for Management Review
External Document Control
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Retrieval of superseded documents and archiving of digital records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
Change Control Management
Managing the Group Change Management programs and databases in alignment with ISO 13485 requirements and ensure 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
Customer Complaint Management
Managing the Group Customer Complaint Management programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed
Customer complaint receipt, coordination and maintaining databases and ensure that deadlines are met by the Group in resolving and providing information to the suppliers for product complaints
Assist and support departments with internal complaint investigations, root cause identification and CAPA determination
Notify Product Manager, Sales Manager and Sales Rep promptly on receipt of investigation results for reporting to customer
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
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
Calibration Management
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
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
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
RAD con, NRCS, ICASA License Applications
Assistance With Sahpra Applications
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