Work Flexibility: Onsite

KEY RESPONSIBILITIES / DUTIES主要职责:

Responsible for developing, applying, revising, and maintaining quality standards/procedures to support manufacturing activities. Making sure the GMP and ISO13485 requirements are implemented correctly and followed strictly.

Review NC report to check its compliance to procedure requirements, and ensure proper NC/CAPA process is followed strictlyMaintain NC/CAPA log system to ensure its accuracySupport CAPA Leader to manage CAPA metrics and prepare weekly/monthly reportSupport CAPA Leader to deliver the required NC/CAPA training, and improve CAPA processDCC related work independently (maintain document master list, record archiving, distribution & retrieval)CM related work independently (ECR scan & registration, Coordinate Basic Windchill training & testing)Other task assigned by supervisor

SUPERVISORY RESPONSIBILITIES管理职责:

None

REQUIRED SKILL SET岗位技能：

 Excellent logical thinkingEffective interpersonal and trouble-shooting skillsGood communication skills and training skills.Basic PC skills & good operation skills of ExcelQuick learner

RELEVANT EXPERIENCE

经验要求：

3  years above in Quality Assurance or related functional area preferredExperience in GMP or ISO quality systems

EDUCATION

教育背景：

College / B.S. in engineering or engineering related discipline.

Travel Percentage: None