QA and Regulatory Officer

Introduction

To own, drive, and ensure effective closure of CAPAs, nonconformances and customer complaints, while maintaining and continuously improving the Quality Management System in compliance with ISO 13485 and MDSAP. This role requires a technical/mechanical engineering background to support long‑term implantable medical devices, including machined and additively manufactured components, and to draft manufacturing and equipment validation documentation.

• Drive ownership and timely closure of CAPAs, nonconformances and customer complaints, ensuring robust root cause analysis and effectiveness checks.
• Draft, review and approve manufacturing, process, packaging, sterilisation and equipment validation protocols and reports (IQ/OQ/PQ).
• Provide technical QA oversight for machined and additively manufactured long‑term implantable medical devices.
• Continue implementation and maturation of the MDSAP programme across the organisation.
• Coach and train staff at all levels on quality system, CAPA and regulatory requirements.
• Support and facilitate internal, supplier and third‑party audits and ensure effective audit responses.
• Document control of all documents used in implementing and maintaining the quality management system.
• Perform quality review of documentation (Procedures and related forms and records).
• Facilitating the effective and appropriate close out of nonconformances, by
• Liaising with the appropriate departments to ensure actions and corrective actions are taken to address the root cause.
• Ensuring the process has been documented and supporting evidence has been included.
• Where applicable, facilitate the process risk management procedure and ensure appropriate preventative actions are taken and all activities are documented.
• Facilitate departmental internal audits.
• Assisting with the facilitation of all third‑party audits as directed by the department manager.
• Assisting with the facilitation of supplier audits as directed by the department manager.
• Identify areas to improve the QMS and facilitate required action.
• Offer regulatory support to departments related to product development, including, where needed, assisting in the writing or reviewing of technical documentation and clinical evaluations.
• Provide and facilitate training to staff for quality‑related processes and procedures.
• Support day‑to‑day activities associated with maintaining QMS compliance.

• Tertiary (university) degree required. Preferably in the engineering discipline or natural sciences.

• 2 years

• Good communication skills – writing, presentation and interpersonal communication (Good writing skills a fundamental requirement).
• High ethical standards
• Good understanding of statistics
• Computer literate:
  Microsoft Office

Salary
: R 25 000 CTC pm.

Hours
: 07:00am to 16:00pm

Availability
:
Immediately or 01 July 2026