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
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.
In return, we offer you
We offer experiences and opportunities that add many unexpected and enriching moments to our employees’ lives. Especially when the innovative health technologies and solutions they help develop benefit their own friends and family.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .