杭州招聘

职位描述：
The Quality Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The position is responsible for the development, implementation, improvement and continuous reinforcement of established Quality fundamental practices that are utilized in the local business.

The Responsibilities
? Responsible for ensuring regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
? Responsible for the development, implementation and continuous improvement of process effectiveness and efficiency at the site.
? 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.
? 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.
? 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 action and improvement programs.
? 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.
? Demonstrated understanding or aptitude to understand ISO quality management system requirements and regulatory requirements.
? Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
? Demonstrated experience using word processing, spreadsheet, and presentation software.
? Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S,)
? Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
? 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 Action & improvement, complaints & risk management; & product quality improvement
? 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
? Exceptional analytical, problem solving & root-cause analysis skills
? 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
? 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
? Energizing others by building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others
? Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely
The Requirements
? Bachelor’s degree (or high school diploma/GED plus 4 years working experience in Quality Engineering or Quality Assurance Management).
? Five or more years exposure to multiple quality engineering disciplines preferred
Interpersonal Contacts
External
? Vendors, suppliers and facility support contractors
Internal
? Technicians, engineers, purchasing, manufacturing, operations, project coordinators, project managers and project assistant

Work Environment
? Working conditions include the possibility of working long hours during project deadline, moderate workload pressure, some evening work, and occasionally working alone.
? Working in a manufacturing environment.
? Infrequent exposure to chemicals depending on the project, building temperature fluctuations, noise.
? May include domestic/international travel for installation and support (requiring current passport).

Physical Demands
? The employee is required to communicate with staff including talking and hearing. The employee may occasionally lift up to 25 pounds; bend, stoop, grasp. The employee may be working at a personal computer workstation for long periods.

we are a foreign-funded professional consultancy company.