QMS Quality Specialist

What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.Basic Function and Scope of the Position:This individual will work as part of China QMS team in the manufacturing site. The individual will be responsible for managing aspects of the Quality Management System related to quality system and regulatory compliance, especially in the processes of document control, audit and CAPA.Tasks and Responsibilities:Maintain and continual improvement on quality system process, ensure QMS effectiveness and complianceCoordinate internal audit program and external audit. Collaborate with stakeholders to ensure timely follow-up, completion and documentation of corrective actions.Coordinate and process documents, Change Requests (CR), Change Notices (CN’s) and Deviations using change control procedures and Enterprise Resource Planning (ERP) systems.Responsible for QMS documents management and maintenance;Establish and maintain training matrix with cross-function  Coordinate cross-functions to execute CAPA program;All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Preferred Education:Bachelor’s degree in Biological/Life Sciences.Preferred Requirements:2-5 years of relevant experience of quality assurance in an in vitro diagnostics environment preferred.Good understanding of GMP, ISO13485 preferred.岗位基本职能与工作范围： 作为中国质量管理体系团队的一员在生产现场工作。将负责管理质量管理体系中与质量体系和法规遵从相关内容，特别是在文件控制、审计和CAPA的过程中。 岗位任务与职责： 维护并持续改进质量体系流程，确保质量管理体系的有效性和合规性。协调内部审计计划和外部审计。与利益相关者合作，确保及时跟进、完成并记录纠正措施。使用变更控制程序和企业资源规划（ERP）系统协调并处理文件、变更请求（CR）、变更通知（CN）和偏差。负责QMS文件的管理和维护。建立和维护跨职能部门的培训矩阵。协调跨职能部门，执行CAPA计划。 所列要求为本工作岗位的基本职能，在不同的业务情况下可能会做出合理增加任务和职责的调整。 期望的教育背景： 具备生物/生命科学专业的学士学位。 期望的经验： 2-5年体外诊断环境质量保证相关经验者优先。对GMP、ISO13485有良好理解者优先Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.