工作职责Responsibilities:
• Ensure all electrical products are manufactured, tested and released in compliance with applicable quality and safety standards and in accordance with the product specification(s) 保证所有的电器类产品制造、测试、放行完全根据产品规格及质量要求与安规标准。
• Work closely with suppliers to ensure quality and safety standards are understood and maintained与供应商密切合作，确保品质及安全标准的理解与执行保持。
• Support suppliers with remediation plans to continually improve product quality, safety, manufacturing efficiency and regulatory compliance 支持供应商进行持续改善并符合依从产品质量、安全、生产效率及法规要求。
• Confirm product manufacturing records are appropriate for product release确保产品生产记录与产品放行相符合。
• Identify and escalate and where possible resolve any major and / or critical observations immediately发现问题、解决、提升相关的关键或主要的质量问题。
• Identify and document all quality and product safety issues and escalate as necessary识别、记录所有的品质及产品安全问题并提升改善。
• Conduct internal and external audits in collaboration with the QA Manager与品质经理合作组织内部审核及外部审核工作。
• Accountable for providing regular feedback on key matters such as post-audit remediation对审核出的关键问题给予定期的反馈
• 教育要求Education Requirements:
• BSc or equivalent tertiary qualification in a relevant engineering degree本科学历，工程类专业
• 经验要求Experience Requirements:
• Demonstrable understanding of quality compliance and product safety requirements of electrical products (for domestic and export markets). 对国内市场及出口市场的电器产品的质量和产品安全要求有深入的了解。
• Ideally a minimum of 2 years' experience in a Quality Assurance / Engineering role; preferably in the Medical Device / pharmaceutical industry or, a similar highly regulated / healthcare industry. 2年及以上品质保证工程师工作经验。医疗器械、制药、医疗保健相关行业优先。
• Understanding of Quality Management Systems and requirements for adherence. 深入理解品质管理体系及相关要求。
• Supplier liaison and relationship management供应商联络及关系管理。
• Adherence to business processes in a regulated environment.在受控环境下坚持业务流程。
• Audit of 3rd party suppliers审核第三方供应商。
• 
  
• 能力要求：
• Ability and willingness to learn new skills and adopt alternative ways of working whilst working strictly in compliance with regulatory, quality, product safety and Company standards学习意愿和能力强。在严格遵守法规、品质、产品安全及公司标准同时，能采用不同的工作方式解决问题。
• Problem solving and critical thinking 解决问题能力及批判性思考问题能力。
• Good written and spoken English 英语听说读写能力良好。
• drive license 持有小车驾驶证.

职能类别： 医疗器械生产/质量管理

微信分享

联系方式