QA Officer - Medical Devices I

Responsibilities

• 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.

• 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.

• Management of Quality Management System Compliance for All Group of Companies in alignment with the requirements of ISO 13485 ensuring deadlines are not missed.
• Generation 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.

• Set 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 requirements.
• Managing 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.

• Managing 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.

• 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.

• Support with External Audits as per allocated actions.
• 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.
• 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.

• Matric (Grade 12).
• Degree:
  Science/ Medical / Biological/ Technical/ Quality (Preferred).

• Advanced Computer Skills (MS Office – Word, Excel, Powerpoint, Teams) - Non-Negotiable.
• 2-5 years working experience in the medical industry – Non-Negotiable.
• Experience with data collection and trending.
• 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.

• Highly organized, with attention to detail, producing and expecting highly accurate work within allocated timelines.
• Methodical and logical structure of executing activities.
• Excellent interpersonal skills.
• Ability to develop, lead, and maintain an effective action completion.
• Fluent in English, verbal and written;
• Ability to operate & communicate at all levels – verbally & in writing.
• Able to follow and issue verbal and written instructions.
• Flexible, conscientious approach.
• Logical approach to good problem solving and solution driven.
• Positive attitude, Energetic and able to work independently.
• Follow up skills and ability to be assertive in meeting deadlines.
• Willingness to learn and someone who has a hunger to grow and make a difference.
• Ability to work under pressure.

• Salary:
  Market Related