QA Officer
Provide day-to-day supervision, task allocation, and guidance to QA Team
Review work outputs for quality, accuracy, and timeliness
Provide coaching, performance feedback, and skills development support
Ensure quality tasks are prioritised and deadlines are met
QUALITY PROCESS MANAGEMENT
Management of Quality Management System Compliance for All Group of Companies in alignment with the requirements of ISO 13485 ensuring deadlines are not missedGeneration of KPI data, Trend analysis data and provision of reports timeously monthly and for Management Review. Follow up with all sites and departments on monthly KPI data metrics. Ensure data is provided as per approved KPI Metrics
RISK MANAGEMENTSet Up Process and Risk Files and continuous maintenance and improvement of the system
Analysis of risk and implementation of corrective actions for Quality Management Systems. Support Teams with Product Risk Assessments in accordance with Group policies and procedures, ISO 13485 and statutory and regulatory requirementsManaging the Group Risk Management programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed
Trend KPI data and provide report timeously for Management Review
VALIDATIONManaging and Maintaining Validation Schedules
Generate validation protocols and reports and support departments where applicable
Support in validation activities for areas under responsibility
Follow up with teams until completion of activities
Trend KPI data and provide report timeously for Management Review
INTERNAL & EXTERNAL AUDITSPerform 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 missedSupport 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
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 DocumentsTraining: 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 & EXPERIENCE REQUIREDMatric (Grade 12)
Degree / Diploma : Science/ Medical / Biological/ Technical/ Quality (Preferred)
Advanced Computer Skills (MS Office Word, Excel, PowerPoint, Teams) - Non-Negotiable- 5 Years working experience in the Medical Industry Non-Negotiable
Experience with Quality Management Systems ISO 13485 or ISO 9001 or any other ISO standard Non-Negotiable
Experience with Regulatory Affairs and understanding of regulations Preferred