The Quality Assurance Leader is responsible for the zone’s compliance to GEHC QMS and the local regulatory requirements. She/he is responsible for the quality management system, controls and continuous improvement and establishing best practice standards to assure product safety and quality.

Key responsibilities include:

• 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.

Qualifications:

• 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
• Front line operational responsibility in Field Service but also support technology transfer projects, guide/support sourcing for compliant purchases and support supplier quality initiatives where necessary