General Electric QA Engineer - NPI in Wuxi, China
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 NPI Quality Assurance Engineer is responsible for providing engineering process support in accordance with documented procedures and practices. The NPI Quality Assurance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.
Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
Provide guidance to product development teams as to the required deliverables to ensure compliance throughout product development cycle.
Review, assess and approve product design milestones and deliverables throughout product development cycle to ensure compliance.
Assist engineering/operational quality/compliance representatives to identify compliance risks during the product development cycle.
Educate and train engineering/operational quality/compliance representatives to ensure adoption of design control best practices.
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).
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.
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.
Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
• Bachelor’s degree in engineering (or high school diploma/GED plus 5 years working experience and understanding of product development, manufacturing, quality control and servicing in a medical device environment)
• Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Demonstrated understanding of product development lifecycles, design change and document change control in a medical device environment.
• Analytical/problem solving/root-cause analysis skills
• Strong technical aptitude (i.e. able to read & comprehend technical documentation, ability to comprehend & execute procedures, demonstrated understanding of system documentation)
• Prior experience using word processing, spreadsheet & presentation software
• Working knowledge of English language (oral and written)
• Expertise: Subject Matter Expert (SME) in product design and design controls.
• Demonstrated experience in a regulated business.
• Knowledge of Quality Systems policies and regulations (ISO, GxP, FDA, and other key regulatory bodies) & strong background in medical device Quality Assurance & processes
• Understanding of the new product introduction (NPI) process
• Able to effectively analyze complex quality system requirements & handle multiple tasks with competing priorities
• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
• Demonstrated collaboration, negotiation & conflict resolution skills
• Excellent oral communication & report, business correspondence & procedure-writing skills
• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
• Change agent with energy, passion & enthusiasm to drive change
• Ability to seek & drive alternative solutions/approaches when required
• Ability to multi-task & handle tasks with competing priorities effectively
• Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others
• External Focus: Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment
• Inclusiveness: Energizing others by building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others
• Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely
Locations: China; JiangSu; Wuxi