Job Description

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

•Professional QMS Team, with multiple team peers globally.

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

•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.