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? 職務(wù)描述摘要
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
? 職務(wù)描述
Roles and Responsibilities
? GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
? Review QMS related DMR files according to GEHC QMS procedure during design transfer and production transfer stage to ensure manufacturing related procedures, working instruction, SOP meet product design outputs. Including flowchart, SOP, Check sheet, process validation plan/ report, packing process validation plan/report, tools qualification plan/ reports, production training metrics.
? Analyze medical device regulation change and improve GEHC QMS procedure and local QMS procedure, ensure QMS meet intended country regulation.
? Lead internal audit to ensure GEHC QMS effectiveness and sufficiency, take main contact window during external audit and NB inspection.
? Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
? Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
? Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
? Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.
? Maintain the local Quality Management System and implement global quality requirements. Conduct monitoring and trend analysis for Quality System.
? Participle in manufacture transfer, ensure sufficient processes are in place and being followed for the NPI, transfer, production and sustaining procedure.
? Provide guidance on Quality Assurance/GMP/CE related topics.
? Conduct and support internal, external audits, training and incoming inspection.
Required Qualifications
? This role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelor's degree from an accredited university or college
? More than 3 years’ experience in Quality Assurance or related function area.
? Basic inspection techniques.