Production Quality Assurance & Management Executive

Overview

康诺医疗有限公司（马来西亚） 总部位于中国江苏，专注高品质一次性医用耗材，是出口领先企业，产品远销50多个国家，并通过ISO 13485与CE认证。公司在马来西亚设立新工厂，作为区域总部与核心生产中心。我们重视团队协作与员工成长，办公氛围友好，鼓励工作与生活平衡。在全球顶尖的医疗企业，开启你的下一步！详情请见： Conod Medical (Malaysia) Sdn. Bhd. Conod is a leading Chinese manufacturer of high-quality disposable medical consumables, with ISO 13485 and CE-certified products exported to over 50 countries. Headquartered in Jiangsu with over 10,000 sqm of GMP-certified cleanroom space, we are now setting up a new manufacturing facility in Malaysia as our regional headquarters and production center. We offer a friendly work culture, focus on employee development, and promote work-life balance. Build your future with a world-class leader in medical manufacturing! Learn more at 康诺医疗有限公司（马来西亚） 总部位于中国江苏，专注高品质一次性医用耗材，是出口领先企业，产品远销50多个国家，并通过ISO 13485与CE认证。公司在马来西亚设立新工厂，作为区域总部与核心生产中心。我们重视团队协作与员工成长，办公氛围友好，鼓励工作与生活平衡。 在全球顶尖的医疗企业，开启你的下一步！详情请见： Conod Medical (Malaysia) is hiring : Production Quality Assurance & Management Executive Responsibilities

Monitor and control production quality processes, including raw material inspection, in-process quality checks, and final product release. Assist in the implementation, documentation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and GMP. Conduct routine production line audits to ensure adherence to SOPs and quality standards. Investigate nonconformities and customer complaints, support root cause analysis, and implement corrective and preventive actions (CAPA). Collaborate with production, engineering, and warehouse teams to identify process improvement opportunities. Maintain accurate and up-to-date quality records and prepare reports for management review. Support internal and external quality audits, including customer and certification body audits. Provide training and guidance to production staff on quality procedures and standards. Qualifications

Bachelor’s degree in Quality Management, Biomedical Engineering, Science, or related field. Minimum 2–4 years of quality assurance or production quality experience, preferably in the medical device or healthcare manufacturing industry. Knowledge of ISO 13485, GMP, and regulatory requirements for medical devices. Strong analytical, problem-solving, and documentation skills. Good communication and interpersonal skills; proficiency in English, Mandarin, and Malay will be an advantage. 康诺医疗（马来西亚）诚聘中 ： 生产质量管理执行员 岗位职责 (中文)

监控并管控生产质量流程，包括原材料检验、过程质量控制及成品放行。 协助质量管理体系（QMS）的实施、文件维护和持续改进，确保符合 ISO 13485 与 GMP 要求。 定期开展生产线审核，确保严格遵循 SOP 与质量标准。 调查不合格项与客户投诉，支持根本原因分析，并落实纠正与预防措施（CAPA）。 与生产、工程及仓储团队紧密合作，推动工艺优化与改进。 维护完整、准确的质量记录，并定期向管理层汇报。 协助应对内部与外部质量审核，包括客户审核和认证机构审核。 为生产人员提供质量标准和操作规范的培训与指导。 任职要求 (中文)

本科及以上学历，质量管理、生物医学工程、理学或相关专业优先。 至少 2–4 年质量管理或生产质量相关经验，有医疗器械或医疗制造行业经验者优先。 熟悉 ISO 13485、GMP 及医疗器械相关法规。 具备较强的分析能力、问题解决能力和文件处理能力。 具有良好的沟通与协调能力，能使用英语、中文及马来文者优先。

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