Quality Assurance Leader responsible for compliance with GE Healthcare QMS in Africa. Ensuring product safety and quality while leading continuous improvement activities.
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 & counsel the business managers in the zone with 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 to applicable regulations
Lead and support continuous improvement activities assigned, which may include such areas as: ISO standards compliance, Risk management, and metrics development/implementation
Requirements
Bachelor's degree in Engineering, Medical Device Technology or Scientific Field
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
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