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 strictly
• Maintain NC/CAPA log system to ensure its accuracy
• Support CAPA Leader to manage CAPA metrics and prepare weekly/monthly report
• Support CAPA Leader to deliver the required NC/CAPA training, and improve CAPA process
• DCC 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 thinking
• Effective interpersonal and trouble-shooting skills
• Good communication skills and training skills.
• Basic PC skills & good operation skills of Excel
• Quick learner

RELEVANT EXPERIENCE

经验要求：

• More than 5  years in Quality Assurance or related functional area preferred
• Experience in GMP or ISO quality systems

EDUCATION

教育背景：

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