In this role, you have the opportunity to

• Ensure the quality system requirements and agency regulatory requirements be fully followed and the processes are efficient and effective.

• Ensure the CAPA process to be well implemented and can support the quality system and business continue improvement.

• Ensure quality system complying with relevant international standards and relevant national regulations such as ISO13485, QSR, MDR, CGMP and MDSAP etc.

You are responsible for

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

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

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

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

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

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

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

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

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

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

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

• Organize necessary quality (refresh) trainings for employees

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

You are a part of

• A professional site production & development quality team with international exposure.

To succeed in this role, you should have the following skills and experience

• Education: Bachelor degree or above.

• 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.

• Competencies and skills:

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

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

• Good quality engineering related tools knowledge and implementation skills.

• Good team work spirit and communication skills.

• Good skills of project management.

• Very good English skill.

上班地址：龙东大道3000号张江集电港