Quality Assurance Leader - TME
- GE Healthcare
- Posted 5/8/2017 3:18:49 PM
- Job Function: Quality
- Business Segment: Healthcare Quality
Location(s): Turkey, United Arab Emirates, Saudi Arabia; Istanbul, Dubai, Riyadh
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
The Quality Assurance Leader is responsible for the region’s compliance to industry and regulatory requirements. He/she will be responsible for the quality management system, controls and continuous improvement and establishing best practice standards to assure product safety and quality.
• 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
• Conduct periodically regional QMS and metrics reviews with region top management
• Coach and mentor functional teams on the development, maintenance and simplification of local procedures
• Provide advice & counsel to business managers in the region.
• 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, Manufacturing, Service) to ensure compliance to applicable regulations and drive product quality in the areas of Design, Service and Manufacturing (when applicable)
• Lead and support continuous improvement activities assigned, which may include such areas as: Standards compliance, Risk management, and metrics development/implementation.
• As appropriate, recruit, mentor, coach & train direct and indirect reports, as well as distributors on activities within areas of responsibility
Quality Specific Goals:
1. Region awareness and compliance with the Company Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to the region
2. Ensure implementation of company procedures and proper documentation practices are followed per QMS requirements
3. Coordinate North Africa region internal quality audits and any QMS relevant external audits (ISO certification or authorities monitoring audits). Subsequently ensure closure of nonconformities using an effective CAPA process in a timely manner
4. Conduct quarterly regional QMS and metrics reviews with region top management and follow up on actions and improvements in QMS
5. Manage and monitor implementation of Good Distribution Practices in company owned warehouses or third parties and medical waste disposal per local regulations
6. Complete all planned Quality & Compliance training within the defined deadlines and coordinate completion of all planned Quality & Compliance trainings for employees and distributors in the regions on time
7. Interface with Supplier Quality Team to ensure approval and use of qualified QMS relevant third party suppliers for any services and products provided to the company
8. Identify and report any quality or compliance concerns and take immediate corrective action as required
9. Complete all management reviews in accordance with management controls procedures.
10. Support timely closure of customer complaints, field actions, and quality system non-conformances in partnership with functional teams
11. Interact effectively with team members of Service and Sales teams in the organization
12. Effectively implement & manage programs and processes to meet regulatory requirements within area of responsibility
1. Bachelor's degree in Engineering, Medical Device Technology or Scientific Field
2. Minimum 3 to 5 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry
3. Hands-on experience with FDA 21CFR820, QSR, ISO9001 and 13485, MDD and/or other international quality systems requirements
4. Proven track record in performing external and internal audits
5. Ability to read, analyze and interpret business plans, technical procedures and governmental regulations
6. Effective report, business correspondence and procedure writing skills
7. Good problem identification, multivariable analysis and creative resolution aptitude
8. Proven process development and project management skills
9. Strong computer skills
10. Ability to communicate fluently in English
1. Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions, and external stakeholders.
2. Experience in a global, matrixed organization structure
3. Professional certification as a Lead Auditor
4. Six Sigma training and/or certification
5. Team player with a global mindset
6. Strong Change Management skills
7. Experience in building a Quality System from ground up
8. Front line operational responsibility in Field Service, Manufacturing, Sourcing, or Supplier Management
Locations: Turkey, United Arab Emirates, Saudi Arabia; Istanbul, Dubai, Riyadh