Lead Auditor

Sofomation; South Africa; On-site; ZAR 300 000 - 400 000; Full time

Job summary

An established industry player is seeking a Medical Device Assessor (Lead Auditor) to join their team in South Africa. This role requires a minimum of four years of experience in the medical device sector, with a strong emphasis on auditing and compliance. The ideal candidate will possess a BSc or higher diploma in a relevant field and have a comprehensive understanding of ISO standards, particularly ISO 13485. You will be responsible for leading audits, conducting performance testing, and ensuring adherence to international regulations. This opportunity offers a chance to make a significant impact in a dynamic environment while collaborating with a reputed multi-national client.

Qualifications

• 4+ years in medical device industry with auditing experience.
• Knowledge of ISO standards and relevant regulations is essential.

Responsibilities

• Lead audits and ensure compliance with ISO standards.
• Conduct performance testing and evaluation studies.

Skills

Auditing Skills

Knowledge of ISO 13485

Clinical Trials Experience

Regulatory Compliance

Research & Development

Education

BSc degree in Biomedical Science

Higher Diploma in relevant field

Job description

Opening for a reputed Multi-National client:

Position: Medical Device Assessor (Lead Auditor)

Experience: Minimum 4 years of experience

Job location: South Africa

• BSc degree, higher diploma or equivalent in one or more professional areas viz. biomedical science, microbiology, chemistry, biochemistry or bioengineering, human physiology, medicine, pharmacy, physics or biophysics
• In general, a minimum of four years full-time work experience in a medical device related industry, including two years in one or more of the following: research & development, manufacturing, application of the device in a clinical setting, testing of devices for compliance with standards, conducting performance testing, evaluation studies, clinical trials.
• Wider knowledge of ISO 13485 Standard; must have successfully completed IRCA regd. Lead auditor training courses.
• Third-party auditing experience in the relevant sector with an IAF recognized certification Body.
• Being familiar with relevant International/local laws and industry regulations.
• Preparedness to travel when necessary to visit locations abroad.
• Qualification to other schemes e.g. ISO 9001, ISO 14001 & ISO 45001 will be an added advantage.

**You can apply directly from LinkedIn or share your profile on [e-mail]**

Seniority level

Not Applicable

Employment type

Other

Job function

Accounting/Auditing, Quality Assurance, and Consulting

Industries

Business Consulting and Services, International Trade and Development, and Environmental Services