QA Leader Job GE Healthcare
Quality Control Jobs, GE Healthcare Jobs.
Description:
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.
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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
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