宜兴 [切换城市] 宜兴招聘宜兴质量管理/安全防护招聘宜兴质量管理/测试经理(QA/QC经理)招聘

RAQA Manager(Medical Device)

苏州西艾信息咨询有限公司

  • 公司规模:少于50人
  • 公司性质:合资(非欧美)
  • 公司行业:专业服务(咨询、人力资源、财会)

职位信息

  • 发布日期:2013-12-17
  • 工作地点:苏州
  • 招聘人数:1
  • 工作经验:十年以上
  • 学历要求:本科
  • 语言要求:英语熟练
  • 职位类别:质量管理/测试经理(QA/QC经理)  

职位描述

Responsibility:
? Recommend and maintain quality programs and systems to support corporate quality policy, regulatory requirements, and quality objectives
? Implement and maintain good manufacturing practices (GMP) and following FDA regulatory requirements by continuously auditing the QA process to meet the established requirements
? Ensure compliance with applicable regulations for manufacturing Medical devices in China for both local and export sales
? Open and process complaints per quality system regulations. Ensure timely and effective failure investigations and corrective action per worldwide requirements
? Conduct conformity assessment audits of policies, procedures and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished
? Review product development and design intent to assure quality requirement compliance has been met as established by the FDA and GMP by reviewing product quality issues
? Obtain necessary pre-market clearances and/or approvals from domestic and international regulatory agencies, competent authorities and notified bodies
? Works as a strategic business partner with business clients to proactively and reactively develop and implement practical, timely, and effective business solutions to quality and regulatory issues
? Establish, maintain and appropriate an effective departmental budget by monitoring necessary acquisitions made by the department to ensure attainment of future budgets
? Write, update and review quality assurance procedures
? Evaluate performance and write performance reviews of subordinates by observing and following set policies and procedures to provide feedback to employees of expectations from management
? Manage a quality team by directing the efforts of the team for the purpose of meeting the company’s goals and objectives
? Performs other related duties as assigned

Requirements:
? Bachelor’s degree preferably in science or engineering (4 years of directly related experience can substitute for educational requirement).
? Minimum of 5 years medical device regulatory, quality systems, or equivalent experience is required.
? Creative problem solving, flexibility, and good negotiation skills are necessary to be successful in this role.
? Proven ability to communicate effectively both in writing and verbally with staff at all levels of the organization.
? Technical writing skills preferred.
? Proven ability to drive practical results to a timely conclusion.
? Proficiency with Microsoft Word, PowerPoint & Excel.
? Some travel may be necessary both domestic and international, less than 20%

公司介绍

当你十年寒窗苦读毕业,怎样接轨社会开启自己成功的职业生涯?当你认真工作,努力向上可曾想过应该再弥补些什么知识? 当你的同事获得提升而不是你的时候,你可知道自己哪里做的不到位?当你郁闷无比,又无法直抒胸臆时应该怎样主动解决当前状况?
    
    人生的机遇充满了选择、惶惑与挑战, 什么才是最适合自己的路?-- 临渊羡鱼,不如退而结网
    
    苏州西艾信息咨询有限公司,是一家从事职业规划,中高级猎头、背景调查、整体招聘解决方案以及企业管理咨询的专业机构,我们致力服务各类企业团队建设,并积极为个人提供职业发展规划建议以及能力提高的方式方向指导。客户与候选人的双赢是我们追求的永恒目标。我们服务过的行业包括快速消费品,化工,半导体,IT, 医药, 工业,装配生产以及研发领域。西艾咨询将坚持遵循高度的职业伦理,秉承“合作、高效、客观”的作风,为企业和职场人提供更为优质的服务。
     
     西艾咨询的愿景:
 成为口碑最好的职业规划平台
 做优质企业与人才的最佳桥梁
     
     西艾咨询的主要服务内容包括:
 职业规划
 中高级猎头服务
 背景调查
 整体招聘解决方案
 性格与高考志愿选择服务
Email: hr@3L-consulting.cn

联系方式

  • Email:hr@3L-consulting.cnRequirements
  • 公司地址:苏州工业园区东环路1500号现代创展大厦1109室
  • 邮政编码:215021
  • 联系人:西艾咨询
  • 传真:(0512)62961203
  • 电话:(0512)62720400