北京招聘

Essential Responsibilities
1. Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.2. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.3. Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, LEAN Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.4. Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.5. Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).6. Develops risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.7. Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.8. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

Role Summary/Purpose

This role is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. Responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.

Qualifications/Requirements

1. B.S. Degree in business or technical field or equivalent experience 2. 1-year experience in a medical device or pharmaceutical industry. 3. 1-year experience with CA/PA systems, including complaint handling. 4. Thorough familiarity with cGMPs of sterile product manufacture 5. Knowledge of relevant Electronic Management Systems transactions and familiarity with Excel / Word packages

Desired Characteristics

1. Statistics education and or training 2. Experience developing and tracking quality metrics 3. Familiar with Continuous Improvement methodologies, including Six Sigma

About Us

GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。