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| 560572-Quality Engineer MD 55 - 118k (J#13315) Education: Bachelors Degree Experience: 1 - 3 years Essential Functions (Responsibilities): The Quality Engineer is a critical role in enabling the business to attain and sustain world-class quality in its products and services. * The right candidate will be a subject matter expert in quality systems and design controls and will provide leadership, guidance and training to cross-functional personnel in the Global Maternal & Infant Care business * The right candidate is: -Experienced in multiple facets of product development& realization and complete product life cycle as they apply to medical device quality management systems. -Will need to be able to work well on their own and possess global skills to manage teams and drive compliance in a matrix organization. -Successfully interface with both internal and external customers as well as top organizational leadership. -Strong leadership and decision-making skills as well as exceptional organizational and communication skills are required. Critical thinking and problem solving skills a must. Qualifications/Requirements: * Bachelor's degree in Biology, Chemistry, Engineering, or Medical Device Technology (or HS degree/GED and a Minimum 7 years equivalent experience in product development, manufacturing, quality control and servicing in a medical equipment environment. * Minimum 3 years professional experience in quality * Previous experience in design controls, design verification and validation. * Previous experience in the development, implementation, and maintenanceof Quality System documentation. * Previous experience conducting internal or external quality audits. Desired: * Master's degree in Engineering or Medical Device Technology * Previous departmental and cross-functional team leadership/mentoring. * Product quality improvement using tools such as six sigma, DFR. * Ability to read, analyze and interpret technical documentation. * Team player able to work successfully in a remote team environment. * Global mindset. Strong global communication skills * Six Sigma Green Belt Certification. * Local second language skills are a plus. * Experience with CAPA, complaints, risk management (14971), and root cause analysis. * Certified Lead Auditor is a plus * Previous experience with US or international quality system and standards requirements (13485, QSR820, ISO9001). General: Clinical Systems - Maternal Infant Care is a $150M business growing at double-digit rates globally, supporting Life from its earliest moments. This is a great opportunity for a sole contributor to learn about the Maternal Infant Care business at the Headquarters located in Laurel, MD. Join our team to help us grow to $300M by 2008! GE is an equal opportunity employer. There are 2 Quality Engineer Roles open in Laurel, Maryland. | |||
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