Overview
高级质量工程师 Jobs in Chengdu, Sichuan, China at 士卓曼(北京)医疗器械贸易有限公司
Title: 高级质量工程师
Company: 士卓曼(北京)医疗器械贸易有限公司
Location: Chengdu, Sichuan, China
该职位来源于猎聘 公司平台：士卓曼旗下联耀医疗 This role is based in Alliedstar, a company acquired by Straumann Group. 关于联耀医疗 ABOUT ALLIEDSTAR 作为牙科专业人士信赖的合作伙伴，联耀致力于通过技术创新提供高效、可靠的数字化解决方案，以适应不同的临床需求，最终帮助口腔诊室提升诊疗体验，在实践中追求卓越。 As a trusted partner for dental professionals, Alliedstar strives to deliver intuitive and reliable digital solutions by advancing technology around clinical demands. We empower dental enthusiasts to level up patient care and achieve excellence in their everyday practice. 我们的使命是坚持引领创新，为牙科专业人士提供先进易用的数字化解决方案，成就更多人的高品质生活。 Our mission is to enrich lives with innovative and easy-to-use digital solutions for dental professionals. 主要工作职能： Major Responsibilities: 先期质量策划 Advanced Quality Planning
- 负责新产品在工厂投产过程中各个阶段质量策划，确保符合所有的产品规格；
Perform quality planning according to the product development procedure, ensure that all product specifications are met.
- 识别新产品导入所需的检测设备，并完成对设备的验收和确认； Identify the testing equipment required for new product introduction and complete the acceptance and validation of the equipment.
- 组织相关人员，对新产品制造过程的关键工序和特殊工艺进行识别，并对关键工序的验证计划、特殊工艺的过程确认方案和报告进行批准；
Organize relevant personnel to identify key processes and special processes in the manufacturing of new products and approve the verification plan for key processes as well as the process validation plan and reports for special processes.
- 主导控制计划、认证计划、检验指导书、量测计划、测量系统分析的制定与实施，并培训； Owns control plan, qualification plan, inspection instruction, measurement plan, MSA, and train inspectors accordingly.
- PFMEA 小组核心成员。 Work as a key team member of PFMEA. 变更管理 Change Management
- 负责新物料、新设备、新工艺导入阶段的质量风险评估与改善，并负责制定相应质量控制计划和相关的质量文件; Conduct quality risk assessments and improvements during the introduction of new materials, new equipment, and new processes, and formulate corresponding quality control plans and relevant quality documents.
- 负责针对现有物料、设备、工艺等变更的质量风险评估，验证计划、过程确认方案和报告的批准; Perform quality risk assessments for changes in existing materials, equipment, and processes, and approve verification plans, process validation plans, and reports. 质量改进 Quality Improvement
- 推动内部质量问题解决和纠正措施制定； Drive to handle the internal quality issues and make corrective actions;
- 协助和参与客户投诉处理，主导与工厂有关的问题改善，跟踪和确认各项改进措施的有效性； Assist in and participate in handling customer complaints, take the lead in addressing factory-related issues, and track and verify the effectiveness of improvement measures;
- 带领跨职能团队完成过程审核，寻求更多改善机会; Lead the cross-function team to plan and implement process audit to seek more improvement opportunities;
- 定期召集质量改善会议， 报告和推动产品质量持续改善。 Regularly convene quality improvement meetings to report on and drive continuous product quality improvement. 任职要求： Requirements: 熟悉ISO 13485、MDSAP等体系要求； Familiar with ISO 13485, MDSAP, and other quality management system requirements; 熟悉质量7大手法和工具，英语可作为工作语言； Familiar with the seven key quality tools and methodologies, English can be used as a working language; 较强的判断力、分析能力和表达能力；
Strong judgment, analytical, and communication skills; 5年以上工作经验，本科及以上学历。 At least 5 years of work experience, Bachelor’s degree or higher.
