About the position
Well known medical equipment supplier requires an experienced QA / RA Administrator. This position is based in Midrand.
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)
Desired Skills:
- ISO13485
- ISO9001
- medical file
- regulatory
- quality
- SAHPRA
- ICASA
