Quality & Regulatory Administrator
1 week ago
**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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