2-5 Years working experience in the medical industry under a Quality Management System
Matric / Gr 12 is the minimum requirement for this position
Qualification in relation to Quality Management Systems is preferred
Diploma, N-Dip or B-tech Degree: Science/ Medical / Biological/ Technical/ Quality is preferred
$ads={1}
Lead Auditor ISO 13485:2016 or ISO 9001:2015 Certification will secure
Project Management qualification will be advantageous
Quality Management System
Advanced Computer Skills (MS Office Word, Excel, Powerpoint, Teams]
Date Issued: 24 February 2023 Internal Use Only Page 3 of 3
Experience with data collection and trending
Experience with Quality Management Systems ISO 13485 or ISO 9001 or any other ISO standard (Required)
Experience with CAPA, Non-conformance, Self-inspections or Internal Audits, Supplier Quality
Experience or working knowledge in Regulatory Affairs and understanding of regulations associated with SAHPRA, Radiation Control, NRCS, ICASA (Preferred)
Required working knowledge of ISO 13485:2016 Quality Management Systems, with experience preferred
Working knowledge of Validation practices;
Working understanding of CE Products, FDA approved products
Must have a valid drivers licence and own vehicle
Must be willing to travel locally and internationally
Must have a valid passport
CAPA
Managing the Group and individual site Corrective and Preventative Action programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed
Support departments with investigations and determining root causes of non-conformities and determining CAPA plans
Trend KPI data and provide report timeously for Management Review
Nonconformance / Deviation Management
Managing the Group and individual site Non-conformance/ Deviation databases in alignment with ISO 13485 requirements and ensure deadlines are not missed
Support departments with investigations and determining root causes of nonconformities and ensure CAPAs process initiated where required
Trend KPI data and provide report timeously for Management Review
Internal and External Audits
Perform allocated internal audits as assigned
Managing the Group and individual site Internal Audit databases in alignment with ISO 13485 requirements and ensure deadlines are not missed
Support departments with investigations and determining root causes of nonconformities and ensure CAPAs process initiated where required
Trend KPI data and provide report timeously for Management Review
Support with External Audits as per allocated actions
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 per timelines.
Trend KPI data and provide report timeously for Management Review
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
Risk Management
Managing and maintaining the Risk Files for areas under responsibility in alignment with ISO 13485 requirements and ensure deadlines are not missed for associated activities
Trend KPI data and provide report timeously for Management Review
Validation
Managing and Maintaining Validation Schedules
Support in validation activities for areas under responsibility
Support departments in validation document compilation and review as assigned
Support in execution of validation execution as assigned
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
General
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
Recall and Adverse events
RAD Con, NRC, ICASA Licence Applications
Assistance with Sahpra Applications
$ads={2}
