In this role, you have the opportunity to
Develop, implement and maintain QMS to ensure products and services are designed and produced to meet or exceeding customer requirements and expectation.
Actively participate with cross-functional teams in business and engineering discipline
Guide functional teams to always to do the right thing at the first time.
You are responsible for
Maintains, enforce, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes
Be accountable to manage and harmonize all QMS management processes and ensure compliance to FDA, MDD/EU-MDR , ISO 13485 and China GMP
Provide guidance to local team and actively contributes to all aspects related to quality, process and applicable regulatory requirements
Review and approve QMS documents and records, ensuring GDP compliance
Manage the transition /deployment of the PQMS and manage its deployment
Plan, coordinates, and execute internal QMS audits to ensure compliance with internal and external requirements and to identify and implement improvement opportunities within the organization.
Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.
You are a part of
To succeed in this role, you should have the following skills and experience
Education: Bachelor degree.
Experience: At least 5 years of QMS management experience in medical industries is required
Competencies and Skills:
Good command of English and Chinese Language skill is required.
Be familiar with ISO 13485, ISO 9001, CRF 820 ,MDD 93/42/EEC or EU-MDR.
Excellent organization and coordination.
Experience of leading a team is preferred.
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.
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 .