Quality & Regulatory Administrator

2 weeks ago

Stellenbosch, South Africa Sinapi Biomedical (Pty) Ltd. Full time

**Sinapi Biomedical manufactures medical devices in Stellenbosch and seeks to employ a full time Quality & Regulatory Administrator. Opportunity to gain experience in the quality control and regulation of medical devices. A strong administrative ability is required with at least 3 years’ experience in working in a high-quality environment. Tertiary qualification in a science, engineering or biological field essential.**

**Skills and experience**:

- **Experience working with a quality management system standard (such as ISO 9001, FSC 22000, ISO 13485, etc)**:

- **Thorough understanding of good manufacturing practices and quality systems**:

- **Strong attention to detail**:

- **Proficient in report and procedure writing**:

- **Root cause analysis and problem solving**:

- **Good communication and people management skills**

**Duties may include**:

- **Maintaining Quality Management System documentation**:

- **Control of Device Master File transfer and changes**:

- **Driving Corrective and Preventative Action process**:

- **Assisting in technical writing for medical device files

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