Responsibilities:

Prepare procedures, operating instructions for quality function, required for compliance of ISO 9001, ISO 13485 & Chinese GMP.

Manage storage, archival & distribution of documents.

Ensure obsolete copies of documents are withdrawn from use & current documents are available at point of use.

Support quality control, quality system management.

Train team members on applicable procedures and work instructions.

Manage inspection, calibration related to assembly function & coordinate with other dept./team.

Effective implementation of quality assurance procedures so as to ensure customer satisfaction & continuous improvement.

Compilation of Quality data & metrics & preparation of report.

Manage all inspection instrument, inspection gages, and test fixtures/tooling/equipment.

Ensure product specifications are implemented in manufacturing processes.

Support Quality management system implementation & maintenance.

Requirement:

3+ quality management experience,3+ site quality control experience in pharmaceutical, IVD or medical device industry

Experienced in documentation ISO 9001, ISO 13485, GMP, CFDA,

Knowledge in process quality control.

Good at communication, coordination

Be good at English

上班地址：新加坡科技园