QA and Regulatory Officer

People Dimension; Centurion; On-site; ZAR 253,890 - 304,110; Full time

Job summary

People Dimension in Centurion seeks a Quality Management professional responsible for ensuring the effective closure of CAPAs, nonconformances, and customer complaints. The ideal candidate has a technical engineering background and a strong understanding of quality systems, with a focus on compliance with ISO 13485.

The role includes drafting validation protocols, facilitating audits, and coaching staff. A tertiary degree in engineering or natural sciences, along with a minimum of 2 years of experience, is required for this position.

Qualifications

• Minimum of 2 years experience in quality management.
• Strong writing skills essential for documentation.
• Technical/mechanical engineering background preferred.

Responsibilities

• Ensure closure of CAPAs, nonconformances and customer complaints.
• Draft and approve manufacturing and validation protocols.
• Provide technical QA oversight for implantable medical devices.
• Coach staff on quality systems and regulatory requirements.
• Facilitate internal and supplier audits.

Skills

Good communication skills

High ethical standards

Good understanding of statistics

Computer literate: Microsoft Office

Education

Tertiary degree in engineering discipline or natural sciences

Job description

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.

Duties & Responsibilities

• 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.

Desired Experience & Qualification

Required minimum education:

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

Required minimum experience:

• 2 years

Competencies:

• 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

Package & Remuneration

Salary: R 25 000 CTC pm.

Hours: 07:00am to 16:00pm

Availability: Immediately or 01 July 2026