Quality Assurance Manager

2 days ago

Cape Town, South Africa Zeal HR Full time

An excellent opportunity has become available for a Quality Assurance Manager within the medical device industry. The role is based in the Cape Town area.

**Requirements**:

- Bachelor’s degree in Science, Quality or Production Management
- 3+ years’ experience in the medical device industry supporting Manufacturing Operations
- Experience in supporting internal/external audits (ISO 13485)
- Successful track record for identifying and implementing systemic corrective and preventive actions
- Can work independently and within a team
- Good communication skills (verbal and written)

**Responsibilities**:

- Establish, implement, and maintain processes needed for the management system, as per ISO 13485
- Report to Top Management on the performance of the management system and lead improvement activities
- Supports the CAPA process, collaborating with owners to ensure effective root cause analysis and the development of innovative, long-term solutions
- Leads problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices
- Develops and implements quality control process sampling systems, procedures, and statistical techniques
- Performs supplier evaluations and manages supplier complaints
- Manages the device history record process including localized document control activities
- Maintains Internal and External Audit program per ISO 13485
- Prepares for and facilitates the annual Management review meetings, minutes and follow-ups
- Provide cross functional day to day support to any QMS related requests or issues

**Salary**: Market related

**Please note**:

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