Production Quality Assurance

4 days ago

Kampung Bukit Minyak, Penang, Malaysia ROZER STERILIZER TECHNOLOGY (M) SDN. BHD. Full time

Rozer Sterilizer Technology (Malaysia) Sdn. Bhd.

Rozer Sterilizer Technology is a professional third-party provider of ethylene oxide (EO) sterilization services, established in 2014. Headquarter in Changshu, China. Rozer serves global medical device manufacturers and has been registered with both the U.S. FDA and the Japan Ministry of Health, with certifications from TÜV SÜD.

With years of expertise and a strong commitment to quality, Rozer has built state-of-the-art sterilization facilities and is expanding operations to Malaysia. Our new Malaysian plant will serve as astrategic hub for Southeast Asia, offering world-class sterilization capacity, strict compliance with GMP standards, and reliable supply chain support.

At Rozer, we value integrity, innovation, and excellence. Join us to be part of a company that safeguards global healthcare through sterilization technology.

Learn more at

荣瑞灭菌技术(马来西亚)有限公司

荣瑞灭菌技术有限公司成立于 2014 年,是一家专业的环氧乙烷(EO)第三方灭菌服务提供商,总部位于中国常熟。公司为全球多家医疗器械生产企业提供灭菌服务,已通过 美国 FDA 注册和 日本厚生省注册,并取得 TÜV SÜD 认证。

凭借多年的行业经验与技术积累,荣瑞在中国已建成高标准灭菌设施,并正在将业务拓展至马来西亚。马来西亚新工厂将成为东南亚区域的 战略枢纽,提供符合 GMP 标准的世界级灭菌产能与高效的供应链支持。

荣瑞秉持诚信、创新与卓越,致力于通过专业灭菌技术保障全球医疗安全。欢迎加入我们,共同打造国际领先的灭菌平台。

详情请见:


Rozer Sterilizer Technology (Malaysia) is hiring : Production Quality Assurance & Management Executive

Job 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.

Requirements:

  • 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.

荣瑞灭菌(马来西亚)诚聘中 :生产质量管理执行员

岗位职责:

  • 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:

  • 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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