400-885-9898
职位描述
医疗器械质量管理体系
A Day In The Life Of Our Senior Design Quality Engineer - ME/EE
Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.
● Review hardware and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy.
● Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management.
● Serves as a technical resource for risk management activities for hardware and systems in compliance with ISO 14971 and IEC 60601.
● Review test plans, and test cases based upon the product and component level requirements ensuring that appropriate statistical techniques are applied.
● Partner with Human Factors SMEs and R&D to assess the usability of a device throughout design and development
● Review and approve V&V system maintenance such as reworks and modification and tracking.
● Review root cause analysis of identified design issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
● Perform audits of Design History Files and support both internal and external audits.
● Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
● Support field service engineering requests and assess serviceability risks.
● Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.
● Work collaboratively and efficiently in a fast-paced environment with minimal supervision and guidance.
● Maintain trained status for and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.
● As the voice of quality, this role will apply and promote best-practice use of statistical tools and techniques throughout the organization.
● Other QMS activities not specified here and as assigned.
About You
● Familiar with FDA, NMPA, EU regulations and international standards related to MD.
● Familiar with ISO13485, ISO9000 and ISO14971, IEC60601 series ... standards.
● Experienced in design development quality, program management process, and better has experienced as system design engineer.
● Disposable hardware experience is necessary, other capital hardware experience is plus.
● Experience with sterilization medical devices including specific standards associated with sterilization is necessary.
● Experienced in leading and supporting internal audit and external audit from 3rd party.
● Familiar with NC/INV/CAPA process, complaint handling process.
● An all-English working environment, good at speaking and writing.
● More than 5 years' working experience in large international medical device enterprises.
工作地点
天津东丽区华明低碳工业基地-B6号楼
认证资质
营业执照信息
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职位发布者
张女士/HR
三日内活跃立即沟通
天津普利方舟医疗科技有限公司天津普利方舟医疗科技有限公司（以下简称“普利方舟医疗”）是美国 Noah Medical在中国的全资子公司。普利方舟的百川系统为Noah Medical的Galaxy系统在中国国产化替代产品。产品基于我们全新一代的医疗机器人平台开发，致力于为肺部疾病患者提供全新的早期诊断和治疗方案。全球现已拥有超400人的精锐团队，我们不仅拥有行业先进的技术，更有来自世界众多知名医疗公司的管理层人员，具备敏锐的洞察力以及丰富的创造力。期望在我们的努力下，打造出革命性的新一代手术机器人产品，造福于人类。公众号可关注：https://mp.weixin.qq.com/s/UGuTIiM5ekgQ5jScGXMrOQ
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