**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：** + 1-3 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. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.