Are you an experienced auditor with a passion for quality in the medical device industry? Join our team as an ISO 13485:2016 Lead Assessor at JC Auditors, a leading conformity assessment body with a client-focused approach to promoting medical device performance and efficacy.

• Location: South Africa – Hybrid
• Employment Type: Freelance Contract
• Industry: Medical Devices | Quality Assurance | Regulatory Compliance
• Experience: Minimum 5 years
• Travel: Extensive

What You'll Do:

• Conduct ISO 13485:2016 audits for medical device manufacturers and suppliers
• Assess compliance with regulatory and quality requirements (SAHPRA)
• Provide expert guidance on risk management, QMS implementation, and continual improvement
• Work with a dynamic team committed to upholding the highest industry standards

What We’re Looking For:

• BSc Degree in one or more health science professional areas (biomedical science, medical science, microbiology, chemistry, biochemistry, bioengineering, human physiology, pharmacy, physics)
• Certified Lead Auditor for ISO 13485:2016 (IRCA registered course preferred)
• Minimum of 5 years work experience in the medical device industry
• Proven experience in auditing medical device organizations and conducting 3^rd party- audits
• Current Audit Log reflecting all completed audits and technical areas
• Strong experience in medical devices, SAHPRA regulatory compliance and quality assurance
• Knowledge of related standards (ISO 14971, ISO 9001) and global regulatory frameworks
• Knowledge of MD5, MD9 and ISO 17021
• Ability to travel
• Excellent communication and stakeholder engagement skills
• Excellent analytical, writing and reporting skills

Why Join Us?

• Work with a globally recognized conformity assessment body
• Opportunity to make an impact in the medical device industry
• Professional growth and continuous learning

📩 Interested? Apply now or share with your network! Contact us at info@jcauditors.com or visit www.jcauditors.com/medical to learn more.