Quality Assurance Specialist

3 days ago


مصر, Egypt Kinetic Full time

A leading **Medical Device** company is actively recruiting a **Quality Assurance Specialist for** their **Egypt** office.

**The main responsibilities will include but not limited to**:

- Facilitates all product registrations and applicable documentation.
- Communicate expected product changes, collect information on the impact, and inform key stakeholders, manufacturers, and/or distributors.
- Monitor and ensure corrective actions are carried out in the affected area.
- Coordinate and facilitate quality risk management and performance development.
- Set QA Objectives and ensure targets are achieved.
- Assess company/suppliers’ product/service specifications and comparing with customer requirements.
- Performs investigation of quality complaints, accidents, and incidents to determine causes and preventive measures.
- Coordinate with suppliers to resolve quality and compliance issues.
- Write technical and management system reports.
- Provide quality-related-trainings.
- Perform internal audit as required.
- Updated on relevant regulations, guidelines, and standards.

**To be successful you will need to meet the following**:

- **Bachelor’s degree,** preferably Pharmacy or Pharmaceutical Sciences.
- **Minimum 3 years’ experience in Medical Devices/ IVD Registrations.**:

- **Minimum 2 years’ experience in ISO 9001:2015 / ISO 13485:2016 Implementation & Certification**.
- Good Knowledge of QA and RA requirements, compliance regulations, and industry practices.
- Excellent verbal and written English.
- Motivated, proactive, dynamic, methodical, organised, and decisive.
- Applicants should be available for face-to-face interviews in the location mentioned above.

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