Job Description:
61 Ensuring the quality system and documentation in area of responsibility
61 Ensuring the implementation of internal and external quality requirements in the area of responsibility (e.g. Q-policy, GMP, ISO 13485,NMPA)
61 which you are responsible:
61 Ensuring that records comply with Good Documentation Practices and Regulations
61 Effectively interacting with all levels of the organisation to resolve issues and associated corrections in device records
61 Participation in the change control process include completion of tasks in the area of responsibility
61 Management review data collection/document control
61 Internal and external audit planning and implement
61 QMS gap analysis and problem-solving
61 Ensuring NC/CAPA comply with ISO 13485/NMPA and QMS requirements

Qualifications:
61 At least 3-5 years experiences on GMP
61 2-4 years experiences on quality system set up for ISO 13485 and NMPA requirements
61 At least bachelor degree
61 Very good English communication skills and ability to work as team member on multiple tasks as well as act as a lone wolf
61 SAP user skills