The Quality Assurance Leader is responsible for ensuring the zone's compliance with GEHC Quality Management System (QMS) and local regulatory requirements across Africa. This role involves managing the quality system, controls, and continuous improvement initiatives, and establishing best practice standards to assure product safety and quality.
Key Responsibilities
- Participate in the development and maintenance of the region Quality Management System (QMS) and relevant processes to assure product quality and safety.
- Ensure company procedures and proper documentation practices are followed per GE Healthcare QMS requirements.
- Attend region/zone QMS and metrics reviews with service and business management functions.
- Coach and mentor functional teams on the development, maintenance, and implementation of local procedures (if any).
- Provide advice and counsel to business managers in the zone regarding QMS-related processes.
- Assist the Quality Assurance Site Manager (when applicable) in preparation for internal/external audits and implementation of corrective actions to address non-conformities.
- Work closely with other functional areas (e.g., Marketing, Engineering, Service) to ensure compliance with applicable regulations.
- Lead and support continuous improvement activities assigned, which may include areas such as ISO standards compliance, Risk management, and metrics development/implementation.
- Hold front line operational responsibility in Field Service, and also support technology transfer projects, guide/support sourcing for compliant purchases, and support supplier quality initiatives where necessary.
Qualifications and Requirements
- Bachelor's degree in Engineering, Medical Device Technology, or Scientific Field.
- Experience and understanding of product development, manufacturing, quality control, and servicing in the medical equipment or pharmaceutical industry.
- Knowledge and experience with ISO9001 and 13485, and/or other international quality systems requirements.
- Proven track record in performing external and internal audits (preferred).
- Ability to read, analyze, and interpret business plans, technical procedures, and governmental regulations.
- Strong computer skills.
- Ability to communicate fluently in English.
