Quality Assurance Manager

A Health Tech Solution Company located in Pretoria is actively seeking a dynamic Quality Assurance Officer to assist in maintaining a company-wide Quality Management System (QMS) and supporting medical device certifications.

Responsibilities include:

1. Maintaining documentation for specifications and procedures.
2. Providing guidance to the internal team on regulatory and quality matters.
3. Staying informed about the latest local and international standards.
4. Ensuring registration and compliance with relevant authorities and notified bodies.

Requirements:

Minimum Education (Essential):

• Certificate or higher in health sciences, biomedical technology, business administration (experience essential), or equivalent.
• ISO 13485 certification.
• Internal auditor certification.
• ISO 14971 certification.
• IEC 62304 certification.

Minimum Applicable Experience (Years):

• Certificate: minimum 5 years.
• Diploma: minimum 3 years.
• Degree: minimum 2 years with at least 1 year in Quality Management & Assurance, developing and implementing QMS according to EN ISO 13485.

Experience:

• Experience with Quality Management Systems such as ISO 13485, ISO 17025, 21 CFR 820, MDR 2017/745.
• Knowledge of regulatory frameworks for medical devices in SA, USA, or EU.
• Experience with EN 62304 implementation (beneficial).
• Experience in preparing technical documentation for FDA or CE marking of SaMDs (beneficial).
• Internal auditor experience (beneficial).
• Experience in the medical device or related technology industries (beneficial).

Skills and Knowledge (Essential):

• Knowledge of ISO 13485, MDR, UKCA, or FDA regulations.
• Proficiency in MS Office or GSuite.
• Report and proposal writing skills.
• Knowledge of internal audits.
• Good communication and reporting skills.
• Self-driven, organized, problem-solving skills.

Key Responsibilities:

Quality Management (40%):

• Define quality procedures and drive the development and implementation of QMS.
• Conduct internal audits and support supplier management.
• Assist with management reviews and maintain medical device risk files.
• Conduct training on QMS and manage change adoption.

Regulatory Compliance (40%):

• Maintain facility and product registrations.
• Ensure compliance with medical device regulations.
• Coordinate post-market surveillance and regulatory documentation.
• Communicate with notified bodies and support software development for medical devices.

Record-Keeping (20%):

• Maintain documentation, SOPs, and records across departments.