南京招聘

Hill-Rom Job Title: Senior QA Specialist

Department: RAQA

Reports To: Dotted report to Head of RAQA China, Direct report to QA APAC,

JOB SUMMARY

1. Based in Shanghai, this role’s responsibilities are composed by post-market surveillance coordination with APAC PMS related functions and establish/maintain QMS per China GSP(Good Supply Practice) regulation for Hillrom Commercial Shanghai.

ESSENTIAL DUTIES AND RESPONSIBILITIES: – Other duties may be assigned:

· Serves as the core-team member for Regulatory Affairs/ Quality Assurance function.

• Document, implement and maintain processes and procedures required for an effective Quality Management system.
• Collect and coordinate information and prepare Periodic Risk Evaluation Report (PRER) for submission to regulatory agencies.

• Review labeling and labels for compliance with regulatory requirements.
• Review changes to existing products and SOPs to define the requirements for regulatory submissions.
• Maintain current knowledge of CFDA and international regulation, guidance and standards applicable to company products
• Establish, maintain and enforce company Quality Management System per GSP. Conduct training programs as needed for internal and external stakeholders.

• Measure monitor identified quality metrics and perform proper root cause analysis to close all issues.
• Ensure all product related complaints are captured into complaint management system and resolved.

• Support training to ensure proper implementation and use of procedures as required.
• Other duties as assigned

Reporting Structure

• Direct Reports: Nil. This role is an individual contributor role
• Peers: RA Specialist and QA Specialist

EDUCATION AND EXPERIENCE:

• Familiar with relevant National or International quality system standards (China GSP, FDA, NMPA), Knowledgeable in ISO-9001/13485 is a MUST
• Working knowledge of China NMPA medical device regulatory requirements
• Experience with New / Existing Product Development that includes product registrations with the regulatory agencies
• Experience in managing third party logistics suppliers.
• Experience with active Class II devices is preferred.

QUALIFICATIONS AND SKILLS:

• B.S. Degree in Science and Engineering field with at least 5 – 7 years relevant experience within the GSP/quality assurance discipline
• Related Quality Certifications are must, work in multinational/international company experience is a plus
• Ability to define problems, analyze data, establish facts and draw conclusions.
• Excellent analytical decision making and problem-solving skills
• Good written and verbal communication skills in English.
• Good interpersonal, analytical and organizational skills.

Hillrom是全球领先患者护理产品和服务的供应商，为急症护理，长期护理和家庭护理环境提供各种产品和服务。Hillrom所提供的产品和服务包括：设施评估、患者护理病床、担架、治疗床垫、序贯性挤压治疗装置、护士通讯系统、工作流程系统、病床床头医疗设备带系统和病房家具。Hillrom全球总部在美国芝加哥，目前全球员工有10000人左右。

2000年，美国屹龙国际有限公司上海代表处在上海注册成立。主要负责中国地区的产品推广和售后服务。随着公司业务的发展，2013年,在上海注册成立了熠隆医疗设备（上海）有限公司。

2014年，通快医疗被Hillrom正式收购。通快医疗是一家全球知名的医疗设备制造商和医疗技术服务供应商，其产品主要包括手术室一体化解决方案，手术床和检查床，外科手术灯，视频解决方案和供应系统。通快医疗最典型的特点是技术创新。在通快医疗历史上，最具代表性的是在临床应用领域的革命性产品理念和产品开发。2005年，通快医疗研发了世界***款LED灯。这些医疗照明的创新为外科和临床医生提供了更优的照明条件。
通快医疗设备（太仓）有限公司成立于2005年初，坐落于太仓中德工业园，主要产品包括手术床及吊塔。

2015年，伟伦医疗被Hillrom正式收购。伟伦医疗是一家全球知名的医疗设备制造商和医疗技术 服务供应商，其产品主要包括视力筛查仪，桌面诊断设备等。
伟伦医疗设备（苏州）有限公司成立于2012年，主要产品包括视力筛选仪和一次性听诊器。


作为业界的领导者，Hillrom为员工提供具有挑战性的工作体验、温馨友善的工作环境和完善的福利待遇。然而，就最重要的原因而言，选择在Hillrom工作就意味着员工有机会将他们的真诚和热忱投入工作中，创造不平凡的业绩。

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