美国医疗耗材公司因业务需求新增职位，负责Field团队所有质量工作。要求英文口语熟练沟通，有较强的leadership

上海火车站附近上班（地铁1,3,4,12,13号线可直达）,苏州Homebase.

感兴趣可把简历发到karen.kong@db-talent.cn的邮箱，或者加V.X：1.3.9.1.7.3.9.1.5.7.3

工作职责：

1. Assist Head of Q&R to implement Quality Management System in design, manufacturing , complaint handling of Quality control

2. Develop quality management system strategy and plan according to business and technology development need

3. Working together with each process on establishment and improvement of processes to fulfill quality system

4. Ensure that production and process is strictly followed by team and all quality requirements are fulfilled;

5. Establishment of quality management system complying with identified standards and regulations, implementation and maintenance of quality management system in the organization

6. Integration and optimization of processes in quality management system to adopt Philips Ultrasound Business Group requirement

7. Initiate and facilitate CAPA process in the organization and follow up of agreed actions.

8. Cooperate with CAPA managers or other stakeholders to support the CAPA investigation and get tasks done timely.

9. Organize the CAPA review meetings to monitor the CAPA phases and escalate any potential risk if have.

10.Plan and organize management reviews, initiate continuous improvement process.

11.Report on the performance of quality management system implementation; define necessary actions including resources to continuously improve the effectiveness of quality management system.

12.Organize necessary quality (refresh) trainings for employees

13.Act as a consultant for quality regulations in the organization and a coordinator for external audits

工作要求：

1. Education: Bachelor degree or above.

2. Experience: More than 8 years of experience in quality management field, more than 5 years of experience in Medical device manufacturing, more than 3 years in CAPA engineering/CAPA implementation.

3. Competencies and skills:

4. Be family with quality tool of problem solving and or the CAPA/ 8D approach.

5. Be familiar with ISO13485, QSR, MDR, CGMP and MDSAP requirements.

6. Good quality engineering related tools knowledge and implementation skills.

7. Good team work spirit and communication skills.

8. Good skills of project management.

9. Good English skill.

上班地址：上海

我们拥有专业的招聘顾问和专员，具有有多年的猎头从业经验，丰富的经历和广泛的当地人脉，借助