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