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Production Quality Assurance & Management Executive

Production Quality Assurance & Management Executive

Conod MedicalSeberang Perai, Penang, Malaysia
1 day ago
Job description

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。
  • #J-18808-Ljbffr

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    Production Executive • Seberang Perai, Penang, Malaysia

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