基本要求：
有研发经历或者背景的质量审核或法规注册相关经验；如无，则需要有生产质量工作背景；
英语要能够进行听说读写，因为与国外交流的机会很多；
良好的沟通能力；
应届生如果素质较好也可以接受；
Description:
The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The QA Engineer is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and service.
The QA Engineer may lead programs and initiatives and/or have responsibility for coaching more junior engineers
Key responsibilities/essential functions include:
? Responsible for ensuring 100 percent quality and 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.
? 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 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.
? Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance.
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Meet NPI program milestone dates while approving compliance status of each
5. Ensure 100% completion/closure of all SPRs/risks before product release to market
6. Ensure 100% on time CAPA closure for engineering investigations
Required Qualifications:
1. Bachelors Degree in an engineering or technical discipline (or non-technical degree with 5 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements).
2. 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.
3. 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.
4. 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.
5. Demonstrated collaboration, negotiation & conflict resolution skills.
6. English as working language.
Preferred Qualifications:
1. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
2. Excellent oral communication & report, business correspondence & procedure-writing skills
3. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
4. Change agent with energy, passion & enthusiasm to drive change
5. Exceptional analytical, problem solving & root-cause analysis skills
6. Ability to multi-task & handle tasks with competing priorities effectively
7. 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
8. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely