Qc
4 days ago
岗位职责Job responsibilities
原材料与零部件检验：依照 MDA 认可标准和工厂质量规范，对采购的原材料、零部件开展入厂检验。
Incoming Inspection of Raw Materials and Components: Carry out incoming inspection for purchased raw materials and components in accordance with MDA-approved standards and the factory’s quality specifications.
借助专业设备检测尺寸、物理及化学指标，核查供应商质量证明文件。
Use professional equipment to test dimensional, physical, and chemical indicators, and verify suppliers' quality certification documents.
标识、隔离不合格品，及时反馈给采购及上级，协助处理相关问题。
Label and quarantine non-conforming items, promptly report issues to the procurement department and superiors, and assist in handling related problems.
生产过程质量监控：按标准操作程序对各工序巡回检验，监督工人依工艺要求生产。
In-Process Quality Monitoring: Conduct patrol inspections of each production process according to standard operating procedures (SOPs), ensuring operators follow technological requirements.
抽检关键工序半成品，检测性能、外观等，记录质量数据，反馈问题趋势并提建议。
Randomly inspect semi-finished products at key processes, test performance and appearance, record quality data, report trends, and propose improvements.
成品最终检验：对成品全面检验，确保符合 MDA 法规、国际标准及客户订单要求。
Final Product Inspection: Perform comprehensive final inspections on finished products to ensure compliance with MDA regulations, international standards, and customer requirements.
进行性能测试，检查外观、包装及标识，判定成品是否合格，对不合格品协同处理。
Conduct performance tests, check appearance, packaging, and labeling, determine product eligibility, and collaborate on handling non-conforming items.
质量问题反馈与跟进：将各环节质量问题反馈给相关部门，协助分析原因。
Quality Issue Feedback and Follow-up: Report quality issues from all stages to relevant departments and assist in cause analysis.
跟踪整改措施执行，参与质量分析会议，为改进决策提供数据。
Track corrective action implementation, participate in quality analysis meetings, and provide data for improvement decisions.
检测设备管理：维护、保养检测设备，按规程操作。
Testing Equipment Management: Maintain and calibrate testing equipment, operating according to procedures.
依 MDA 法规和制造商建议校准设备，建立设备档案。
Calibrate equipment in line with MDA regulations and manufacturer guidelines, and establish equipment archives.
上级领导安排的其他工作。
Other duties assigned by superiors.
任职要求Job Requirements
大专及以上，医疗器械、质量检测或理工科相关专业优先。
Education: College diploma or above; majors in medical devices, quality inspection, or related technical fields preferred.
1 年以上医疗器械质检经验，熟悉生产工艺与质控流程，有马来西亚相关经验者优先。
Experience: At least 1 year of medical device quality inspection experience, familiar with production processes and quality control workflows; prior Malaysia experience is a plus.
熟悉质检标准与方法，熟练使用检测设备，了解相关法规标准，具备数据分析能力。
Skills: Familiar with quality inspection standards and methods, proficient in using testing equipment, aware of relevant regulations, and capable of data analysis.
中文、马来语沟通良好，英语能阅读简单质量文件。
Language: Good communication in Chinese and Bahasa Malaysia; able to read simple English quality documents.
工作严谨负责，有责任心与质量意识，具备团队协作和学习能力。
Competencies: Meticulous, responsible, quality-conscious, with teamwork and learning abilities.
持有相关质检资质证书者优先。
Certifications: Relevant quality inspection certificates preferred.
**Job Types**: Full-time, Permanent
Pay: RM2,800.00 - RM3,500.00 per month
Work Location: In person
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