Quality Specialist质量专员
福迪威医疗器械（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资（欧美）
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2019-10-14
- 工作地点：上海-长宁区
- 招聘人数：2人
- 工作经验：5-7年经验
- 学历要求：本科
- 职位月薪：15-20万/年
- 职位类别：质量管理/测试工程师(QA/QC工程师) 认证工程师
职位描述
Major Duties and Responsibilities:
Supports the Market Quality Manager and the local commercial team on all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:
- Implements and supports ASP Quality Management System and its integrated programs within the respective region, such as quality systems training, internal audits, nonconformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance.
- Assures compliance with applicable regulations such as, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, Japan JPAL, Canada CMDCAS, Brazilian ANVISA, and Austrailian TGA.
- Maintains, sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics.
- Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring).
- Maintains quality oversight of any local required establishment licences, or QMS certifications.
- Maintains local supplier/vendor selection, qualification, and audits.
- Maintains process for kitting/repack/relabeling activities (if any)
- Maintains quality records and adherence to records retention policies and procedures.
- Maintains quality oversight of field service processes/procedures.
- Maintains quality training program with respect to quality system elements.
- Establish corrective and preventive actions to mitigate potential or actual noncompliance risks.
- Assesses product quality issues and escalates to upper management through established processes.
- Ensures timely post-market surveillance & vigilance (Field Actions and Product Complaints) management
- Ensures timely and consistent escalation of events.
- Responsible for communicating business related issues or opportunities to next management level
- Performs other duties assigned as needed.
- As assigned by the manager.
Qualifications:
Education:
- BS / BS degree (science or engineering preferred) at minimum
- 5 years of related experience
- Training of medical device regulations to include ISO 13485 and 21 CFR 820 at minimum
- Six Sigma Process Excellence and/or Lean Excellece Green Belt trained (prefered)
- ISO 13485 lead auditor qualifications (preferred)
Years of Related Experience:
- Minimum of 5 years of experience in medical device or pharma regulated environment in the areas of Quality, R&D, Manufacturing, or related field.
- At least 5 years experience in the Medical Device industry
Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
- Demonstrated knowledge of regulatory standards and regulations, FDA 21 CFR 820, EU MD Directive/Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA, ISO 13485, ISO 9001, ISO 14971.
- Ability to work and communicate in a cross-cultural environment.
- Excellent communication skills both written and verbal
- Highly developed influence, interpersonal, communication and conflict resolution skills
- Ability to interact with all levels and disciplines within the organization
- Must be able to work on mulitplie priorities and tasks simulataneously, while acting in a decisive manner and demonstrating a bias for action
- High sense of urgency, adaptable to meet rapidly changing priorities
- Proven analytical/quantitative skills
公司介绍
ASP是全球领先创新灭菌和消毒解决方案供应商，总部位于美国加利福尼亚州欧文市，在世界各地设有多个办事处。 ASP支持医疗机构保护患者免受医源性感染的影响，其解决方案包括提供设备、耗材和软件，用于可重复使用手术器械的低温终端灭菌和高水平消毒。加入我们，共同为患者及其家人、医疗工作者以及社区生活创造安心的环境。
联系方式
- 公司地址：上海市长宁区福泉北路518号9座4楼 (邮编：200335)