Where

Compliance and Quality Coordinator

R 20 000 - R 30 000 a month
Performability Recruitment
Johannesburg Full-day Full-time

Description:

Key Responsibilities:

Regulatory & Compliance (Core Focus)

  • Maintain and enhance the Quality Management System (QMS) in line with ISO 13485 .
  • Ensure all departments comply with ISO procedures , keeping documentation audit-ready.
    Manage SAHPRA license compliance and update medical device files with current certifications.
    Oversee corrective actions, risk assessments, and supplier database updates .
    Liaise with suppliers, customers, and industry bodies to ensure regulatory compliance.
    Assist in product registrations, failure reporting, and returns processing .

Operations & Stock Control

  • Support import/export compliance and assist with stock takes & cycle counts .
  • Update supplier price lists and manage custom product procurement.

Financial & HR Support

  • Assist with fleet management, creditor payments, and financial reporting .
  • Maintain employee records, leave registers, and recruitment coordination .

Requirements:

  • Maintain and enhance the Quality Management System (QMS) in line with ISO 13485 .
  • Ensure all departments comply with ISO procedures , keeping documentation audit-ready.
    Manage SAHPRA license compliance and update medical device files with current certifications.
    Oversee corrective actions, risk assessments, and supplier database updates .
    Liaise with suppliers, customers, and industry bodies to ensure regulatory compliance.
    Assist in product registrations, failure reporting, and returns processing .
  • Support import/export compliance and assist with stock takes & cycle counts .
  • Update supplier price lists and manage custom product procurement.
  • Assist with fleet management, creditor payments, and financial reporting .
  • Maintain employee records, leave registers, and recruitment coordination .
  • 3+ years of administrative experience (preferably in medical devices/healthcare supply).
  • ISO 13485 experience (or strong familiarity with medical industry compliance).
  • Fluent in English with strong documentation skills.
  • Senior Certificate (Matric) – Tertiary qualification is a plus.
  • South African citizen.
  • 3+ years of administrative experience (preferably in medical devices/healthcare supply).
  • ISO 13485 experience (or strong familiarity with medical industry compliance).
  • Fluent in English with strong documentation skills.
  • Senior Certificate (Matric) – Tertiary qualification is a plus.
  • South African citizen.
03 Apr 2025;   from: careers24.com

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