QA Officer – Medical Devices

About the role

The QA Officer will lead quality assurance activities for a portfolio of medical devices, ensuring compliance with ISO 13485 and local regulatory requirements. The role involves supervising a QA team, managing quality processes, and supporting risk, validation, and audit functions.

Key responsibilities

• Supervise the QA team, allocate tasks, review outputs, and provide coaching.
• Maintain the Quality Management System in line with ISO 13485, generate KPI data, and produce monthly management reports.
• Set up and continuously improve risk files, conduct product risk assessments, and manage the group risk management database.
• Manage validation schedules, create protocols and reports, and follow up on validation activities.
• Conduct internal audits, support external audits, and drive root‑cause investigations and CAPA processes.
• Update SOPs and quality documents, handle training administration, and oversee recall and adverse event follow‑up.
• Assist with regulatory submissions such as RAD CON, NRCS, ICASA licences, and SAHPRA applications.

Required profile

• Matric (Grade 12) qualification.
• Relevant degree in Science, Medical, Biological or Technical fields.

Required skills

• Knowledge of ISO 13485 quality standards.
• Risk management and product risk assessment experience.
• Validation protocol development and execution.
• Internal and external audit execution.
• KPI tracking and reporting.
• SOP creation and document control.
• Recall and adverse event management.
• Regulatory submission experience (RAD CON, NRCS, ICASA, SAHPRA).

What we offer

• Opportunity to work in a dynamic medical‑device environment.
• Professional development through coaching and training.
• Exposure to international quality standards and regulatory processes.