Iso 13485 : 2016 Medical Device Lead Assessor

Sapics; Gauteng; On-site; ZAR 200 000 - 300 000; Part time

Job summary

A leading conformity assessment body is seeking an experienced ISO Medical Device Lead Assessor in Gauteng, South Africa. The role involves conducting ISO audits, assessing compliance with regulatory standards, and providing guidance on quality management systems. Candidates should hold a relevant BSc degree and have at least 5 years of experience in the medical device industry. Strong analytical skills and the ability to travel are essential for this freelance contract position.

Benefits

Professional growth and continuous learning

Impact in the medical device industry

Qualifications

• Minimum of 5 years work experience in the medical device industry.
• Proven experience in auditing medical device organizations.
• Current Audit Log reflecting all completed audits.

Responsibilities

• Conduct ISO audits for medical device manufacturers.
• Assess compliance with regulatory and quality requirements.
• Provide expert guidance on QMS implementation.

Skills

ISO auditing

Regulatory compliance

Risk management

Quality assurance

Stakeholder engagement

Education

BSc in health science professional areas

Certified Lead Auditor for ISO

Job description

iso medical device lead assessor

ISO : Medical Device Lead Assessor

Are you an experienced auditor with a passion for quality in the medical device industry?

Join our team as an ISO : Lead Assessor at JC Auditors, a leading conformity assessment body with a client-focused approach to promoting medical device performance and efficacy.

Employment Type : Freelance Contract

Industry : Medical Devices | Quality Assurance | Regulatory Compliance

Experience : Minimum 5 years

Travel : Extensive

What You'll Do:

• Conduct ISO 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 : (IRCA registered course preferred).
• Minimum of 5 years work experience in the medical device industry.
• Proven experience in auditing medical device organizations and conducting 3rd 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 , ISO ) and global regulatory frameworks.
• Knowledge of MD5, MD9 and ISO.
• 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.