Quality Management System Specialist
1 month ago
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
â¢Professional QMS Team, with multiple team peers globally.
To succeed in this role, you should have the following skills and experience
â¢Education: Bachelor degree.
â¢Experience: At least 5 years of QMS management experience in medical industries
â¢Competencies and Skills:
â¢Good command of English and Chinese Language skill is required.
â¢Be familiar with ISO 13485, ISO 9001, CRF 820 ,MDD 93/42/EEC or EU-MDR.
â¢Excellent organization and coordination.
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